Podcasts about De novo

Neste domingo, GP da Bélgica de F1. Por isso, a o Podcast Motorsport.com chega com o programa PÓDIO, que recebe Felipe Motta, apresentador da ESPN e ex-repórter de F1 'in loco', para debater tudo de Spa com Carlos Costa e Guilherme Longo.

Com tanta novidade surgindo no Tour de France, nada melhor do que relembrar uma ótima conversa sobre como alguns equipamentos dos profissionais de alto rendimento podem ser usados por muitos de nós amadores, nas suas diversas opções de marcas e preços.Os conhecimentos científicos sobre o nosso corpo também estão disponíveis, mas poucos de nós se beneficiam.Neste programa, Ana Lídia conversa com Dr. Fabrício Braga, oferecendo dicas e sugestões sobre pontos muito importantes que ele aprendeu e pratica na sua clínica no Rio.

Fontes do episódio aqui:⁠https://portal.afya.com.br/podcasts/afya-news/13-07-2026Nesta segunda-feira, o boletim analisa o desenvolvimento acelerado de soluções biológicas, os impactos das oscilações climáticas no sistema circulatório e o panorama epidemiológico sazonal. Abordamos a autorização no Reino Unido para o início dos ensaios clínicos de um imunizante desenvolvido pela Universidade de Oxford em apenas oito semanas contra uma variante emergente rara na África. Detalhamos o alerta da American Heart Association sobre como a exposição ao estresse térmico extremo sobrecarrega o organismo, exigindo monitoramento preventivo rigoroso em pacientes com insuficiência cardíaca e hipertensão. Por fim, trazemos no Radar o posicionamento da OPAS sobre a simultaneidade de múltiplos patógenos respiratórios sazonais no hemisfério sul e a urgência de impulsionar as coberturas vacinais. Afya News. Informação médica confiável e atualizada no seu tempo.

Diversifique seus investimentos internacionais com liberdade, transparência e facilidade. Conheça a Remessa Online, acesse o site ou baixe o app. [Patrocinado]As forças americanas atacaram o Irã pela terceira vez em uma semana, o que provocou retaliação contra pelo menos cinco nações árabes, enquanto Teerã declarava o Estreito de Ormuz fechado “até segunda ordem”.

Neste sábado (11), nossos comentaristas repercutiram a vitória da Espanha sobre a Bélgica e projetaram os últimos confrontos por vagas na semifinal da Copa do Mundo. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Meta pode ser multada em R$ 7,2 tri em julgamentos sobre vício de jovens em redes sociais. Nintendo confirma nova versão do Switch 2 com grande mudança e redução de até 1% na capacidade da bateria. Pagamentos do smartwatch agora aparecem no histórico da Carteira do Google. Perfil de Neymar na Steam é bombardeado com bandeiras da Noruega. Agência dos EUA usa IA Mythos para encontrar falhas no governo. Tesla, eBay e Siemens pedem fim de tarifas contra produtos do Brasil. E eu sou Amanda Fleure, a companhia de vocês nessa noite no Hoje no TecMundo, seu programa diário de tecnologia que começa depois da vinheta envolvente que o editor vai colocar aí pra gente!

Na pauta do programa Acerto de Contas, da Rádio Gaúcha:Apresentação: Giane Guerra- O brasileiro que vai aos EUA defender o Pix, tão criticado por Trump: "São falácias"- O setor do mel também irá à audiência para evitar o novo tarifaço- Unimed funcionará 24h em shopping após restrição da emergência pediátrica do Moinhos de Vento- Uma avaliação das crises das cooperativas Cotribá, Piá e Languiru- Decretada falência de metalúrgica que terá fábrica lacrada no Vale do SinosProdução: Isadora Terra e João Pedro CecchiniEdição de áudio: Eduarda Brum Patrocínio: Shopping Total, Sindilojas Porto Alegre, Marcopolo, Be8 e Corsan

DCB for De-Novo Lesions

WhatsApp testa mudança que pode exibir mais anúncios no app. Falha no Microsoft Defender permite controle total do sistema a invasores. PS6 deve ser lançado em 2028, indicam analistas após fim da mídia física da Sony. ZeroDelay: extensão para navegadores promete reduzir atraso na Copa do Mundo. Assassin's Creed e mais! Confira os lançamentos de games de julho. Google lança Nano Banana 2 Lite para criar imagens de IA mais rápido. Keeta anuncia entrega diferenciada para pizzas e comida japonesa e Microsoft prepara nova onda de demissões e Xbox está entre as áreas afetadas.

Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients.  Guest links: https://www.bluestocking.health/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 083 - Allison Komiyama [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus. She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies. She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today. [00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here. [00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person." [00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah. [00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech. [00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space. But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well. And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike. [00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping? [00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So. [00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?" [00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing. [00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"? [00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people. So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper. And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born. I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?" And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know about this? Like, what are ways that you can promote yourself and promote what you're doing without misbranding or mislabeling or adulterating anything, right?" You wanna stay within FDA's regulations and not do anything wrong marketing-wise. But it's also something to get really excited about, and I think we've often forgotten that a lot of these medtech devices do really, really cool things, do really amazing work to help people, help people s- you know, improve their quality of life. Let-- Help them survive, get them to live longer, let kids actually make it to adulthood, right? So there's so much good that I wanted to amplify that more. I wanted to get people to not just focus on the negative, right? There is, there is a lot of harm that can come from any sort of drug, device, anything, but there's also a lot of good. And so I think especially right now in the world we need more good things to talk about. Not that I wanna, you know, look at everything through rose-colored glasses. But I do think if we can focus on some of the good that's going on in the world and the things that we have in common, what a great conversation to have. [00:10:14] Lindsey Dinneen: Oh, yeah, I couldn't agree more. And I love the fact that and you're so much fun. You're helping these companies also get excited too, because I think sometimes it's really easy-- I mean, we need to take our industry seriously. It's a serious industry and real life consequences, good and bad, from innovation... [00:10:29] Allison Komiyama: Yes. [00:10:30] Lindsey Dinneen: ...But I think you know, we've, we've talked a lot about this recently, even ar- along amongst just some of my colleagues, is like we're gonna take, we're gonna take our actual work very seriously, of course, but we're gonna not take ourselves super seriously. We're gonna have fun. We're gonna celebrate. We're going to each other why we're here and why we're doing this, 'cause otherwise it can get easy to get kind of bogged down in the, the nitty-gritty. [00:10:52] Allison Komiyama: Oh, it's so easy to spiral. I-- And I feel like a lot of media allows us a-and, and capitalizes on that doom scroll/spiraling of, "Oh gosh, everything's bad." And I wanna be informed, but I also, as you said, I don't wanna take myself that seriously. Like, I have so many hobbies. I laugh a lot. I have really great conversations with people, and I think that's what I, you know... the legacy I wanna le- leave behind is that I made the world a little better than when I started here. And also that I had a lot of joy to share. So yeah. [00:11:31] Lindsey Dinneen: Okay. So I-I'm curious, going back to your days at the FDA, what are some of the common things that you saw where perhaps there's either a misconception about the process of approval or just mistakes you might have seen that were kind of common that maybe those who are listening who are trying to, you know, get through it as, as easily as possible could benefit from? [00:11:54] Allison Komiyama: I think one of the biggest misconceptions and it wasn't anyone's fault, was that FDA are the experts in what you're building. And maybe, maybe folks knew that that wasn't the case. You know, they walk in and they know that they're living and breathing their technology and their device day in and day out. They've been building it for years oftentimes. And so to think that FDA understands your patient population, understands the, the sensor technology or whatever technology you're building understands your software, your materials, all, all the various things that go into a s- a pre-market submission, is a terrible assumption to make, right? Not that you wanna treat FDA like a bunch of dummies, that you're like, "Oh, you guys don't know anything. I'm gonna have to start from, you know, square one here to really walk you through everything." But you definitely want to communicate and be able to tell a really solid story to FDA about what you're building or what you've built, and why you believe it's either safe and effective, or why you believe it's substantially equivalent, or why you believe the benefits outweigh the risks. And so I think if you can be that storyteller, if you can really walk FDA through what it is you've built, and why you think it should be, you know, allowed to enter interstate commerce, you've w- you know, you, you're already ahead of the game. So I think any company that really is trying to figure out what's that first interaction they're gonna have with FDA, whether it be at a pre-submission or just straight to pre-market submission, right? They're just gonna file the, the, the 510K or what have you. Really making sure that you've explained your product and they know why you're there. Otherwise, you are going to cause more questions than answers from FDA, and that's a big concern when you have somebody who doesn't understand what you're doing or why you've built it the way you've built it. That can really set you back. [00:13:56] Lindsey Dinneen: That's great advice. So, so being really prepared to kindly educate while telling the story, but you know, doing so, of course, in a, like you said, a respectful way. But, but having those answers ready, having the narrative really thought out so that you can walk in with that authority, but also explanation and storytelling. Yeah. Okay. [00:14:19] Allison Komiyama: Exactly. Yeah. It is. I mean, I always my-- I've actually, I have a podcast that I f- a few of my guests recently, they've all been expert or experts in how we tell stories, which I love even just... I mean, how we tell stories to our children is very different to how you tell a story to a colleague at work or, you know, the... and there's a way that, once you know your audience and once you know what it is you're trying to convey, there's a very clean path that you can follow. I'm still working on it. I have to, I have to confess, I am not a great storyteller. I have a tendency to get sidetracked and off topic, probably like what I'm doing right now. But, but you know, bringing it back and, like, what are, what are we trying to do? What are we trying to accomplish? And that I think that storytelling is really valuable when you have FDA as your audience. [00:15:15] Lindsey Dinneen: So I know, like you said, you have many hobbies and lots of things that keep you occupied, but you also do a lot of volunteering for boards. And I was wondering if you could share just a little bit about some of that experience and what you're passionate about there. [00:15:29] Allison Komiyama: Yeah. I think I've always been a big fan of volunteering. I think it's one of the ways that I I meet new people, I get involved in s- things that are outside medtech, which I think is extremely valuable. There's so many voices that even if it's not directly in medtech, everyone's impacted by medtech in some way, right? Like I always say, "You're either gonna start in a hospital or end in a hospital, and you're probably gonna go into a hospital at many different times or use a medical device, whether it be on your phone or, well, while you sleep or," you know, for any-- I don't know, there's a million purposes that people use medical devices. And I wanted to have more voices around me that that are, that are helping humanity, but in a different way. So, one of the boards that's always been near and dear to my heart, of course, my rowing club. I love... It's the oldest women's rowing club in the world. It's called Slack Rowing Club, based here in San Diego, and I help with a lot of the programs, but also fundraising, membership, and just, you know, having this really dynamic group of 400 women that some of them row, some of them are just there to be part of a community and help each other, which is pretty marvelous. And we do a lot of actually talks. Like we'll have a speaker series and we'll bring in physicians or we'll bring in people who are talking about sleep and perimenopause and menopause or, you know, various topics that definitely impact our our cohort. It, it's actually kind of similar to Bluestockings, like the original Bluestockings, where we'll have someone come in and talk about architecture. Like there's various things. So I love doing that. It's also-- They're-- The members are from like 12 years old to 102 years old. It's pretty amazing, and just, like, this great dynamic group of women who are fun to volunteer with and also sit in a boat with. The other one that I've joined last year was the International Relief Teams, which works on helping bring some sort of relief to an emergency situation, whether it be floods or fires or famine or war. Like, there's, They partner-- We partner with different organizations that are, like, boots on the ground in those areas to either build houses or get m- meals or get water to where it needs to be in an emergency. So IRT is fantastic. They get, like, one of the highest ratings of nonprofits. The other one is Indy Medtech. Really cool. That's a very medtech-based one. It's a virtual board, but it is building a community of medtech suppliers and people who are just needing support from each other or you know, either hiring or, "Hey, I have a question. Can someone help answer this 'cause I don't know where to go to get the answer to this?" So really cool, and they, they're doing a podcast as well. I love it. And then last but not least is the San Diego Regulatory Affairs Network. So I have been in San Diego, moved here back here, I should -- i'm from San Diego-- but moved back here in 2011, 2012, and I joined the San Diego Regulatory Affairs Network. It's the SoCal... Like, there's a similar one in Orange County, the Orange County Regulatory Affairs, so OCRA, and then there's also, of course, RAPS, and there's a Southern California chapter. And it's just a group of regulatory folks that love to meet up, love to support each other. "Hey, I have this job opening coming up. Hey is there a mentee that would like a mentor?" And so I'm now the VP of programs for that, and once a month we try to have a speaker either virtually or in person. There's gonna be some in-person ones. And I love it. It's just a great way to network, to support each other, and also to learn more cool stuff going on in regulatory. So yeah, that's a smattering of the ones that I'm part of. So, you know, as, as you said, like, it's kind of like they're all over the place, but it definitely makes me feel more connected with humans, with our-- you know, like, and, and not doomscroll. I'm, I'm too busy to doomscroll. So. [00:19:44] Lindsey Dinneen: That's, that's a good thing, I feel like. So, I love that. Okay. Those are g- those are such cool organizations. Thank you for sharing a bit about them. [00:19:51] Allison Komiyama: Yeah. Thanks for asking. [00:19:52] Lindsey Dinneen: Yeah. So all right, I'm curious. Going back, could eight-year-old Allison have ever imagined what you're doing now? [00:20:02] Allison Komiyama: Never in a million years. Yeah, I think I, I knew I loved biology and bugs and science at a very young age, so I knew that I was probably on that trajectory. But if you asked eight-year-old-- or actually, I-- if you asked five-year-old Alison what she wanted to be, the first was hummingbird, and I did... That did not pan out. [00:20:29] Lindsey Dinneen: Dang it. [00:20:29] Allison Komiyama: But and then I would say florist 'cause I love flower arranging, so that is something that I've s- I've kept up with, as you said, like you saw the video of me arranging flowers. I still love doing that. I, I enjoy that creative outlet. But not in regulatory. I didn't really know that regulatory affairs existed as a career especially until I was 26. I mean, which is crazy to think, like I was in grad school, and I took a course on the history of FDA, and I was like, "What is this? This is so exciting, so interesting." And I knew that was something, that something along those lines is what I wanted to do with using my biology and, and neuroscience background, but also how do I maybe get closer to medicine in a certain way? Like, I, I didn't wanna be a medical doctor, but I knew I wanted to help people. Like, I think most people wanna help people. And that was, that was the right pivot for me at that point. [00:21:32] Lindsey Dinneen: Amazing. So, all right. So you've had a bunch of different leadership positions now over the years. And of course, you have led your own company now a couple different iterations, I suppose, of, of what you've been doing. But what has that leadership journey been like for you, especially perhaps how different it is between working for another company where you might be in a leadership role versus leading yourself and your company? [00:21:56] Allison Komiyama: Great question. I-- what was it, what's it been like? I would say there's like equal parts fearlessness, excitement, and terror. I don't know, like I-- maybe those are all kind of, of the same like ilk of those, those feelings. My daughter always says, she's like, "I'm nervous and I'm excited," like before she goes on stage in the talent show, and she's like, "I'm nerve-cited." And I, I, I use that a lot now too 'cause, you know, before I give a talk or before I you know, go on a podcast like this, I'm like, "I'm nerve-cited," 'cause it's gonna be something that I haven't done before, right? Every day is a little different and... But it's also exciting to do. I Yeah. I, I feel like it was not always easy. Like, people are like, "Oh, you made it look so easy and, and just, you know, seamless." And oof, there were moments that I really struggled. It's... You know, there have been times that I really relied on my family, on therapy, on my friends to really help me. And even just, you know, something as simple as I had a friend who made my first website for me. He was like, "You're so busy and stressed," like, "Let me help you." And so I think calling on others and really having people be your community that you've built, right? Like, I think sometimes we try and go it alone, and maybe that's the worst thing to do when you're building something 'cause you really need to rely on others to help you out. And so I've had, you know, I've, I've, I've worked really hard on my network and to build the friends and colleagues that I want to surround myself with, and then I have reached out to them when I knew I need them. So I, for example, I think with Bluestocking Health, I... When I was-- Before I launched in last year, so September of 2025, I called a bunch of folks that I really trusted to tell me if I was going off course or to also help me build stuff. And my advisory board for Bluestocking Health is amazing. Like, they're not all in regulatory, 'cause that's not what I wanted to build. They're in media. They're in quality system, reimbursement, business strategy. Like, there's such a diverse group of folks that will also help be my sounding board, right? Like, I had a couple medical doctors that I reached out to that are on the advisory board that I was like, "I'm thinking of doing this. Can you give me, like, your thoughts pro/con?" And they always are so willing to help, right, if they have the time. It's been extremely rewarding. So I would say that leadership journey, again, not the easiest at times, but also when it gets hard calling on those friends to really support me has been really marvelous. [00:24:49] Lindsey Dinneen: Yeah. You know, that's such an interesting thing because this has come up a lot, especially in the last few episodes and just conversations I've had in the industry of the importance of community and mentorship and surrounding yourself with those good people who you can call and go, "Okay, I have this, I have this, I think maybe crazy idea. What do you think?" Or just, "Hey, life is a little tough right now. Can we just, can we just talk?" So that's... [00:25:15] Allison Komiyama: Yeah. [00:25:15] Lindsey Dinneen: ...Really cool. [00:25:17] Allison Komiyama: Yeah. Absolutely [00:25:19] Lindsey Dinneen: Yeah. Okay. So as you've gone through your career, and especially within the medtech industry, which seems like you've really just, you know, fell in love with and, and stayed, so that's wonderful. Are there any moments that stand out to you as really affirming that, "Yes, I am in the right place at the right time"? [00:25:40] Allison Komiyama: I think every clearance De Novo granting that I've ever been part of, even if my name's not on the file, has been one of those moments where, oh, it feels so good. It feels so great to see those companies make it through FDA. And then also, you know, to the next point or d- you know once they are selling and they're, they're helping patients, I've had clients reach out to me and say, "I just got this amazing testimonial from somebody and I wanted to share it with you because you were part of that journey." And oftentimes I'll say, "Can I share that with the FDA reviewer that helped us 'cause they're still there and I really think that they would value that, that piece of information, just that commentary and that validation." I mean, w- I've had ones where the testimonial was like, "Because of this device, my kid is alive today. My kid would have been-- would have died two years ago if it hadn't been for this product." And like, I even just got chills. Like I-- honestly, it feels like even though I'm not a medical doctor, even though I was, you know, integral maybe in putting their 510K together or their submission together, and I've never touched the device necessarily, I feel so rewarded that it's like, we did it. We did it together, right? And I, I wanna share that with others. I think that's part of what I'm trying to do with Bluestocking Health is like we all are part of this community, and it's not that we just like clock in and we, you know, do document control or, you know, work on our risk assessments and, you know, clock out for the day. It's like, no, we, we do all help save lives, right? What a, what a powerful thing to be part of and to know that that's, that's something that you helped do. I don't know. I, I-- maybe that sounds again a little too like look how great we are. Like how, you know, look at, look at how amazing this space is, but oh, it is. It 100% is, so. [00:27:43] Lindsey Dinneen: No, I could not agree with you more. I've, I've always felt the same way of just like, "Okay, I'm, I'm not the scientist, I'm not the engineer, I'm not the regulatory affairs person. I, you know, I play a very small role. I, I help talk about the devices." I sh- you know, the marketing... [00:27:59] Allison Komiyama: Yes. [00:28:00] Lindsey Dinneen: ...And that's, you know, that's, that's not the biggest component of bringing these devices to market by any stretch of the imagination. But I do get to play a role, and I think that is the coolest thing ever. Yeah. [00:28:12] Allison Komiyama: Yeah. Well, and think of-- I mean, I'm gonna be your hype woman for a second because think of all the people who learn about that tech or understand, "Hey, this might be something right for me or my loved one, and if I hadn't learned about it or if I hadn't you know, been exposed to this idea or even knowing that this is in clinical trials, okay, now I'm gonna go look into the clinical trial." Like, that information sharing and even just talking to people or talking to laypeople, like, there's such an important piece of the marketing and the strategy around that, that it's huge. I-- you know, like, directly or indirectly, you've saved a life, right? How cool is that? [00:28:56] Lindsey Dinneen: Yeah, exactly. How cool is that? It's, it's remarkable. Okay. So, all right. Pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. [00:29:09] Allison Komiyama: Ooh, yes. [00:29:10] Lindsey Dinneen: What would you choose? [00:29:10] Allison Komiyama: I mean, all of the things in my header, I think at LinkedIn. So I lo- but I'll, I'll give you a real answer in a second. I think, I mean, all of the... I love my creative outlets. So I love flower arranging, I love face painting, I love chopping wood. I love cross-stitch and needlepoint, and my daughter and I just started doing crocheting together. So I feel all of those things are so I... Not that I'm a master in any of those things, but maybe it's being willing to try new things or having that, I don't feel, I don't consider myself to be a totally fearless person, but maybe channeling some of that fearlessness and a willingness to try new things, and where do we find that and how do we kinda overcome some of that activation energy sometimes to get to try those new things? And I think innovators have that in spades, right? So a lot of the companies that we work with, they're like, "I have an idea, and I don't know if this is gonna work, but I'm gonna go for it." And I think a lot of those cre- it, it's a creative outlet for them as well, right? They're trying something new. And so maybe it's giving people more more support or more confidence that they can try new things. I feel like I don't love change. Like I, I, as a child, I like, I liked the things that just stay the same. But when you look at my arc and my, my origin story, it has been all about very unsettling moments or, you know, like where I was felt, feeling very unsettled or like trying something new, and I'm so grateful for all of those things, and I'm also really grateful that I did it, right? So a- and again, it came down to a lot of my community, my friends, my family that supported me and said, "Yeah, you can do this," right? Having those hype people to help me. So maybe a masterclass in just like being the hype person for people who wanna try new things and try leadership, right? Or try a new path that they hadn't thought about yet. [00:31:24] Lindsey Dinneen: Like, I think to your point too, the more that you're willing to do that and kind of step a little bit outside of your comfort zone and have that potential for quote unquote "failure." But, you know, first of all, the more you do that, the more resilient you get, which means it's easier and easier and easier to take those first steps, right, into something new. [00:31:43] Allison Komiyama: Yes. [00:31:44] Lindsey Dinneen: But I also think-- I, I often think about it in terms of if you can frame those kinds of moments as "I am exploring, this is an exploration" and not like pass-fail, if you're exploring, there's, there's no chance of failure, right? You can, you can explore something and go, "Ugh, not for me," or you can go, "Oh, I actually love this, but it's hard and I'm gonna have to keep working at it." But I think if you can like kind of maybe take it in a slightly different mental direction, that also helps, you know? [00:32:13] Allison Komiyama: Ooh, I like that. Yeah. Like reframing. This is not, this is not something that's gonna, you know, end in failure, 'cause I agree with you. You know, I've called it failure in the past where it's like, "I'm gonna try things. If this fails, then I'll go do something else," right, which then it's not really a failure. You learned something. But it is being able to change directions. It is the ability to say, "Okay, I figured out that I something from that, and then what am I, what am I gonna do with that information?" So I love that. [00:32:48] Lindsey Dinneen: Oh, that'll be a masterclass. I can't wait. okay. And how do you wish to be remembered after you leave this world? [00:32:55] Allison Komiyama: Oof. I hope I... It's, oof. I, I, I hope to be remembered. Yeah. What does my dash look like? Isn't that what they say? Like, what is the dash between the, the birth year and your the year of your death? I definitely wanna be remembered for, like, what my kids are doing, 'cause I'm pretty proud of, like, how badass both of those girls are. But back to your question. I would like to be remembered as somebody who helped innovators and people who were building in the medtech space to grow their brand, to get their message out there, and to really bring awareness to the benefits of medtech. I think it's so easy, as I said earlier, it's very easy for us to get caught up in the bad and the negative, and here are the risks, and we really are so nervous about the risks of things, as we should be. We should be a res- risk-averse population. Like, they-- I don't wanna be walking towards something that's gonna cause me harm. And at the same time, there's a lot of benefit to what we're doing, and I think if we can I guess what we were just talking about, reframe a little bit and say, "Yes, there's risk. There's inevitable things that are gonna happen, but here's the potential benefit," and how do we h- in a human way, weigh those things so that we can get other people to also see that this is something that could benefit them. So it's sharing that message. I wanna know, be, you know, considered somebody who also didn't take herself too seriously, made people laugh. You know, maybe they showed their, their kid a, a video of me doing something silly, but also maybe there's some kid out there that's like, "Oh, she was talking about regulatory affairs. What's that? Maybe I should look into that as a career option." So, yeah, I hope some of it is inspiring to others. [00:34:48] Lindsey Dinneen: Okay. That's, that's great. And then final question: What's one thing that makes you smile every time you see or think about it? [00:34:59] Allison Komiyama: I wanna say my kids, but really it's probably hummingbirds. I have never lost the total fascination with hummingbirds. They are so interesting. They're so beautiful. There's a lot of them here in San Diego where I live, and I kid you not, last year, a mother hummingbird built her nest right outside of our front door. And so we'd have-- we told our guests, like, "Come through the, the side gate 'cause do not walk close to, to our sweet hummingbird." And she laid two eggs, and I was able to watch these two little hummingbirds grow and fledge. And I... It was just one of-- again, it makes me smile every time I think about it. Every time I see a hummingbird, I'm like, "That might be our girl that, that had, that had her nest right here." So yeah, I think that whimsy, the, the, the fun and just how gorgeous they are. They always bring... sparks me joy, for sure. [00:35:58] Lindsey Dinneen: Absolutely. Me too. I adore hummingbirds. One of my favorites. Yeah, love that. Oh my goodness. Well, this has been an amazing conversation. Allison, thank you so much for taking time today to speak with me, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. Oh my gosh, and just thank you so much for everything you're doing to change lives for a better world. We're grateful for you. [00:36:42] Allison Komiyama: Thank you. It's so nice to be here. Thank you so much for having me on. [00:36:45] Lindsey Dinneen: Absolutely. Until next time. [00:36:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

In this episode of Investor Connect, we hear from Dr. Swarna Balasubramaniam, a surgeon-turned-founder, who presents Noleus Leaf, a perioperative therapeutic device designed to restart bowel function and shorten the long, complication-prone recovery after major abdominal surgery, where patients often remain hospitalized 2 to 14 days waiting for intestines to "wake up." She explains how excess IV fluids swell the intestines, contributing to ileus, and how Noleus Leaf uses negative pressure (vacuum) therapy placed at the end of surgery for six hours and then removed at the bedside to remove fluid and help patients eat and drink sooner, supporting healing. Dr. Balasubramaniam shares first-in-human study results conducted outside the US showing patients tolerated internal negative pressure therapy and bedside removal, and recovered bowel function two days earlier than supportive care. She outlines the market opportunity, citing about 2.9 million patients affected, additional use cases in inflammatory or infectious GI conditions, and economics including a device cost under $300 at scale and potential pricing tied to saving roughly two hospital days. The discussion also covers regulatory and commercialization plans, including pursuing a 510(k) pathway leveraging negative pressure wound therapy predicates rather than a De Novo approach, targeting large tertiary and quaternary surgical centers first, and building a sales motion that requires both surgeon champions and hospital value analysis approval. Dr. Balas notes the company has been capital efficient (under $4 million to date), is raising $1.4 million to support a 10–15 patient trial and verification/validation work for FDA clearance, and anticipates commercialization in about two and a half years, with potential exit paths to large medical device or wound care companies. ________________________________________________________________________ For more episodes from Investor Connect, please visit the site at: http://investorconnect.org Check out our other podcasts here: https://investorconnect.org/ For Investors check out: https://tencapital.group/investor-landing/ For Startups check out: https://tencapital.group/company-landing/ For eGuides check out: https:/_/tencapital.group/education/ For upcoming Events, check out https://tencapital.group/events/ For Feedback please contact info@tencapital.group Please follow, share, and leave a review. Music courtesy of Bensound.

Copa do Mundo começa nesta quinta com formato inédito, em meio a guerra e a política anti-imigração de Trump. Copa do Mundo terá três cerimônias de abertura; veja como serão os eventos. Brasil x Marrocos: Seleção mantém base de estreia em 2022 e terá recorde de remanescentes. Eleições no Peru: Keiko Fujimori lidera sobre Sánchez em nova virada na apuração das urnas. Pauta-bomba: Senado aprova 2 projetos de aumento de gastos públicos e envia outro a plenário. Por que alunos estão vaiando a inteligência artificial em formaturas de universidades dos EUA?

O programa Meio-Dia em Brasília desta quarta-feira, 10, fala sobre a nova queda do senador Flávio Bolsonaro (PL) em levantamento divulgado nesta quarta-feira pela Genial Quaest.Além disso, o jornal também aborda a suspensão do julgamento no Tribunal Superior Eleitoral (TSE) relacionado à pesquisa AtlasIntel e fala sobre a PEC que reduz a maioridade penal no Brasil.Meio-Dia em Brasília traz as principais notícias e análises da política nacional direto   de Brasília.     Com apresentação de José Inácio Pilar e Wilson Lima, o programa aborda os temas mais quentes do cenário político e econômico do Brasil.     Com um olhar atento sobre política, notícias e economia, mantém o público bem informado.    Transmissão ao vivo de segunda a sexta-feira às 12h no nosso canal do Youtube.  https://www.youtube.com/@OAntagonista  Apoie o jornalismo independente. Assine O Antagonista e Crusoé com 10% via Pix ou Google Pay:  https://assine.oantagonista.com.br/   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #FlávioBolsonaro #PesquisaQuaest #GenialQuaest #PesquisaEleitoral #PolíticaBrasileira #QuedaNasPesquisas #SenadoFederal #NotíciasPolíticas #Eleições #AvaliaçãoPolítica

50 dias depois de vencer o IM Texas, Solveig Lovseth vence o IM Hamburgo. Nesta distância, ela já largou 5 vezes venceu 4, incluindo Kona 2025. O que podemos esperar desta norueguesa? Confira o MT News desta semana

Antonelli vence de novo e dispara no campeonato.George Russell é punido por excesso de velocidade nos boxes, zera e não e perde até a vice-liderança do campeonato!SIGA @botequimgp EM TODAS AS REDESContato: botequimgp@gmail.comWhatsapp: 47 99245 3613

Promoção da MARATONA DE SÃO PAULO 2027 - https://cnoar.run/MaratonaSP2017 | Valor promocional de R$ 75 + taxas até o dia 15/6 (3 mil vagas) - Depois disso, será R$ 150 + taxasNeste episódio do CNA News, analisamos a polêmica envolvendo a influenciadora Aline Steffens, que defendeu o uso do tempo do GPS em vez do tempo oficial de prova como recorde pessoal e bloqueou o canal após o envio de uma resposta. Além disso, trazemos discussões sobre o posicionamento de mercado da Maratona de Valência e a alta procura pelas inscrições promocionais da Maratona de São Paulo.Tópicos abordados:- Polêmica do RP: Tempo oficial de prova contra o tempo do Strava e GPS.- Mercado de corridas: As inscrições da Maratona de São Paulo e a estratégia de Valência.Nossos cupons e links - https://cnoar.run/cuponsO Corrida no Ar News é produzido diariamente e postado por volta das 6 da manhã.

O programa Meio-Dia em Brasília desta quarta-feira, 3, fala sobre a nova investida de Donald Trump na economia brasileira, e a expectativa da implantação de duas taxas aos produtos brasileiros.Além disso, o jornal aborda também as consequências políticas desse episódio e como isso vai impactar na campanha eleitoral.O programa também aborda as novas revelações da Polícia Federal sobre Daniel Vorcaro e Ciro Nogueira.Meio-Dia em Brasília traz as principais notícias e análises da política nacional direto   de Brasília.     Com apresentação de José Inácio Pilar e Wilson Lima, o programa aborda os temas mais quentes do cenário político e econômico do Brasil.     Com um olhar atento sobre política, notícias e economia, mantém o público bem informado.    Transmissão ao vivo de segunda a sexta-feira às 12h no nosso canal do Youtube.  https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #tariflávio #podcast #polêmica #internet #virou #meme #debate #notícia #fofoca #áudio #bastidores #comentários #opinião #viral #tendência #episódio #assunto #novidade #atualidade #áudio

No Estadão Analisa desta quarta-feira, 3 de junho, Emanuel Bomfim e Ricardo Corrêa tratam da reação e das estratégias de Lula e Flávio Bolsonaro para lidar com a ameaça de novo tarifaço anunciada pelos Estados Unidos. O presidente brasileiro fez seu mais duro discurso contra o senador. Já Flávio, elogiado por Donald Trump no mesmo dia, negou ter relação com o episódio e divulgou uma carta que teria enviado ao secretário de Estado americano Marco Rubio. Enquanto isso, Tarcísio de Freitas criticou a postura americana e os candidatos da chamada terceira via pouparam Flávio e miraram as críticas em Lula. O programa também analisa a revelação de novas conversas de Daniel Vorcaro nas quais ele dá prioridade máxima aos pagamentos para o filme Dark Horse, que conta a história da eleição de Jair Bolsonaro em 2018. Acompanhe Estadão Analisa com o colunista Carlos Andreazza, de segunda a sexta-feira, o programa traz uma curadoria dos temas mais relevantes do noticiário, deixando de lado o que é espuma, para se aprofundar no que é relevante Assine por R$1,90/mês e tenha acesso ilimitado ao conteúdo do Estadão. Acesse: https://ofertas.estadao.com.br/_digital/See omnystudio.com/listener for privacy information.

NESTA EDIÇÃO. Mais uma vez, bloqueio de recursos ameaça atividades regulatórias na ANP e Aneel. EUA usam etanol para justificar novas tarifas contra produtos brasileiros e indústria sucroenergética reage. Silveira promete novamente portaria para leilão de baterias e Aneel avança na regulamentação dos sistemas de armazenamento. Petrobras eleva preço do diesel, mas neutraliza impactos para consumidores com adesão a subvenção. ***Locução gerada por IA

Host Polly Swingle is joined by Lauren Sauders, MOTR/L, CBIS, CSRS, and Vice President of Medical Affairs at Neurolutions, to talk about the IpsiHand device for stroke recovery.As an occupational therapist by training, Lauren has spent her entire career in adult neurorehabilitation. She began as a clinician at The Rehabilitation Institute of St. Louis, an affiliate of Washington University in St. Louis, where she worked alongside the research team that conceived IpsiHand in its earliest days. She helped author the initial study protocol and has grown with the company ever since - shepherding the technology through clinical trials, peer‑reviewed publications, and the regulatory pathway that earned IpsiHand both FDA Breakthrough Device designation and De Novo clearance. After clearance, she helped lead the organization through commercialization and into broader clinical adoption. Lauren has authored numerous publications and delivered presentations at national and international forums, but her most enduring focus is advocacy: ensuring that stroke survivors have evidence‑based access to therapies that meaningfully improve their quality of life. That mission is personal. Beyond the patients she has cared for, Lauren brought her grandmother into her own home during the COVID‑19 pandemic and cared for her after she sustained a severe stroke — an experience that deepened her understanding of the toll stroke takes on families as well as individuals. She is also a mother of three, including a child with a rare neurogenetic condition, and is a passionate advocate within the pediatric neuro-community as well. Her and her husband also share their home with three crazy dogs. When she isn't working or advocating, she can most often be found visiting family in Bermuda.Click the link below to visit the IpsiHand by Kandu website-https://www.neurolutions.com/Learn more about The Recovery Project!View our website at www.therecoveryproject.netCall us 855-877-1944 to become a patientFollow us on InstagramLike us on FacebookThanks for listening! 

Neste episódio, Denis Botana e Danilo Silvestre falam sobre a vitória do San Antonio Spurs sobre o OKC Thunder no Jogo 7 da Final do Oeste. Os atuais campeões estão eliminados e a NBA terá seu oitavo campeão diferente em oito anos, um recorde. Faremos também o preview da decisão entre o San Antonio Spurs e o New York Knicks, reedição da final de 1999.Durante os PLAYOFFS 2026 o Bola Presa terá duas edições por semana, às segundas e às quintas. ....*SHARKE*Ganhe três meses de consultoria de investimentos na Sharkehttp://sharke.com.br/bolapresa...*APOIE O BOLA PRESA* ASSINE O BOLA PRESA NO APOIA-SE E RECEBA CONTEÚDO EXCLUSIVO https://bolapresa.com.br/assine*CAMISETAS INSIDER*Use o cupom BOLAPRESA e ganhe 15% OFF, já aplicado automático se usar o link abaixo:

Claudio Portella Isabelle Magalhães, Letícia Marques e Pedro Dep analisam a derrota de virada do Botafogo para o Bahia pela 18° rodada do Campeonato Brasileiro e repercutem os bastidores do clube. Dá o play!

crecas e turbulências impediram a nave de alçar voo normalmente. mas esse VAPODN#44 (vale a pena ouvir de novo) vem na medida para comemorar os 8.5 de dylan, celebrados dia 24, relembrando o especial “dylan / basement tapes” com eduardo bueno! programa histórico que foi ao ar pela primeira vez em 30dezembro2014! vem… confira AQUI … Continue lendo o #703 em modo “vale a pena ouvir de novo” com o aniversariante da semana… →

Kimi Antonelli vence o GP CANADÁ e dispara na liderança do campeonato graças à quebra de Russell. Mas o que marcou neste fim de semana foi o duelo dos dois pilotos da Mercedes que gerou reclamações do piloto italiano pedindo punição pro companheiro de equipe e bronca de Toto Wolff.Será que a partir de agora acabou a paz?Bem-vindo ao Botequim GP, o seu canal de Fórmula 1Nosso objetivo é explorar a verdadeira essência do automobilismo com profundidade, rigor histórico e sem sensacionalismo. Produzimos documentários e análises para quem quer entender as engrenagens da categoria máxima do esporte a motor.O que você encontra por aqui:- A História Não Contada: Os bastidores, os grandes milagres e os projetos que marcaram época.- F1 & Negócios: Como o dinheiro, o marketing e a política de bastidor moldam os resultados na pista.- Retrospectivas: Reedições imersivas de temporadas clássicas que definiram gerações.Opinião e Análise: Visão crítica e embasada sobre as notícias e polêmicas mais importantes do paddock atual.Inscreva-se e venha debater com a gente. Para os apaixonados por engenharia e regulamentos, conheça também o nosso Clube de Membros para vídeos exclusivos e aprofundados.

O programa Meio-Dia em Brasília desta sexta-feira, 22, fala sobre as novas mentiras de Flávio Bolsonaro na crise desencadeada pelo Banco Master e pelas ligações do parlamentar com o banqueiro Daniel Vorcaro.Além disso, o jornal também aborda a aprovação de um projeto de lei que flexibiliza a doação para prefeituras e fala sobre os destaques da semana e da Revista Crusoé.Você já leu uma notícia hoje e sentiu que já viveu esse momento antes?   Essa sensação de déjà Vu não é coincidência. No Brasil, o que é manchete hoje costuma ser o eco de decisões e fatos que analisamos meses, ou até anos atrás.   Para celebrar os 8 anos da Crusoé, decidimos enfrentar esse ciclo. Pegamos o que nasceu no digital e, pela primeira vez, transformamos em um registro físico, tátil e permanente.   Chegou a edição especial Crusoé impressa.   É um item colecionável, atemporal e limitado. Uma revista feita para quem gosta de ler com calma, longe das notificações do celular. Um exemplar para guardar sobre o que realmente importa na história recente do brasil.   Esta edição é um presente exclusivo para novos assinantes do Combo de 2 anos O Antagonista e Crusoé.   Utilize o cupom 8ANOSCRUSOE e acesse o link:   https://bit.ly/crusoe-edicao-impressa  Meio-Dia em Brasília traz as principais notícias e análises da política nacional direto   de Brasília.     Com apresentação de José Inácio Pilar e Wilson Lima, o programa aborda os temas mais quentes do cenário político e econômico do Brasil.     Com um olhar atento sobre política, notícias e economia, mantém o público bem informado.    Transmissão ao vivo de segunda a sexta-feira às 12h no nosso canal do Youtube.  https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #FlavioBolsonaro #MentiuDeNovo #Politica #Noticias #PodcastBR #Debate #Atualidades #Trending #Internet #Mundopolitico #Informacao #Jornalismo #Polematica #Escandalo #Senado #Governo #Opiniao #Fatos #AnalisePolitica #Repercussao

Senador agora é flagrado utilizando cotão do Senado para fazer viagem a São Paulo após banqueiro ser solto pela PF.Você já leu uma notícia hoje e sentiu que já viveu esse momento antes?   Essa sensação de déjà Vu não é coincidência. No Brasil, o que é manchete hoje costuma ser o eco de decisões e fatos que analisamos meses, ou até anos atrás.   Para celebrar os 8 anos da Crusoé, decidimos enfrentar esse ciclo. Pegamos o que nasceu no digital e, pela primeira vez, transformamos em um registro físico, tátil e permanente.   Chegou a edição especial Crusoé impressa.   É um item colecionável, atemporal e limitado. Uma revista feita para quem gosta de ler com calma, longe das notificações do celular. Um exemplar para guardar sobre o que realmente importa na história recente do brasil.   Esta edição é um presente exclusivo para novos assinantes do Combo de 2 anos O Antagonista e Crusoé.   Utilize o cupom 8ANOSCRUSOE e acesse o link:   https://bit.ly/crusoe-edicao-impressa  Meio-Dia em Brasília traz as principais notícias e análises da política nacional direto   de Brasília.     Com apresentação de José Inácio Pilar e Wilson Lima, o programa aborda os temas mais quentes do cenário político e econômico do Brasil.     Com um olhar atento sobre política, notícias e economia, mantém o público bem informado.    Transmissão ao vivo de segunda a sexta-feira às 12h no nosso canal do Youtube.  https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #FlavioBolsonaro #Vorcaro #Politica #Noticias #Repercussao #Senado #AudioVazado #Debate #Jornalismo #Fatos #Apuração #Atualidades #GiroDeNoticias #Contestação #Midia #DiscussaoPolitica #Informacao #RedesSociais #PodcastDePolitica #AnalisePolitica

Christian M. Spaulding and C. Michael Gibson look at the 1-year results from the study comparing sirolimus-eluting DCB with DES for de novo coronary lesions.

No Papo Antagonista desta terça-feira, 19, falamos sobre uma pesquisa AtlasIntel/Bloomberg que aponta que o senador Flávio Bolsonaro perdeu seis pontos percentuais em um eventual cenário de segundo turno contra o presidente Lula.O recuo do parlamentar na corrida presidencial ocorre após a repercussão do vazamento de mensagens enviadas por ele ao banqueiro Daniel Vorcaro.Você já leu uma notícia hoje e sentiu que já viveu esse momento antes?   Essa sensação de déjà Vu não é coincidência. No Brasil, o que é manchete hoje costuma ser o eco de decisões e fatos que analisamos meses, ou até anos atrás.   Para celebrar os 8 anos da Crusoé, decidimos enfrentar esse ciclo. Pegamos o que nasceu no digital e, pela primeira vez, transformamos em um registro físico, tátil e permanente.   Chegou a edição especial Crusoé impressa.   É um item colecionável, atemporal e limitado. Uma revista feita para quem gosta de ler com calma, longe das notificações do celular. Um exemplar para guardar sobre o que realmente importa na história recente do brasil.   Esta edição é um presente exclusivo para novos assinantes do Combo de 2 anos O Antagonista e Crusoé.   Utilize o cupom 8ANOSCRUSOE e acesse o link:   https://bit.ly/crusoe-edicao-impressa  Papo Antagonista é o programa que explica e debate os principais acontecimentos do dia com análises críticas e aprofundadas sobre a política brasileira e seus bastidores.       O programa traz contexto e opinião sobre os temas mais quentes da atualidade.       Com foco em jornalismo, eleições e debate, é um espaço essencial para quem busca informação de qualidade.       Ao vivo de segunda a sexta-feira às 18h no nosso canal no Youtube.   https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #Flávio #Vorcaro #MentiuDeNovo #Podcast #Polêmica #Internet #Viral #Bastidores #Repercussão #Canais #Mídia #Exclusivo #Revelações #Engajamento #Atualidade #Debate #Conteúdo #Audiência #Notícias #AltaNaInternet

Não deu mais para esconder. O senador Flávio Bolsonaro convocou os parlamentares do PL e admitiu publicamente que foi pessoalmente à casa de Daniel Vorcaro no fim de 2025, logo após o ex-banqueiro ser preso pela Polícia Federal.Por que um pré-candidato à Presidência foi se encontrar com um investigado usando tornozeleira? Veja os bastidores dessa crise.Você já leu uma notícia hoje e sentiu que já viveu esse momento antes?   Essa sensação de déjà Vu não é coincidência. No Brasil, o que é manchete hoje costuma ser o eco de decisões e fatos que analisamos meses, ou até anos atrás.   Para celebrar os 8 anos da Crusoé, decidimos enfrentar esse ciclo. Pegamos o que nasceu no digital e, pela primeira vez, transformamos em um registro físico, tátil e permanente.   Chegou a edição especial Crusoé impressa.   É um item colecionável, atemporal e limitado. Uma revista feita para quem gosta de ler com calma, longe das notificações do celular. Um exemplar para guardar sobre o que realmente importa na história recente do brasil.   Esta edição é um presente exclusivo para novos assinantes do Combo de 2 anos O Antagonista e Crusoé.   Utilize o cupom 8ANOSCRUSOE e acesse o link:   https://bit.ly/crusoe-edicao-impressa  Papo Antagonista é o programa que explica e debate os principais acontecimentos do dia com análises críticas e aprofundadas sobre a política brasileira e seus bastidores.       O programa traz contexto e opinião sobre os temas mais quentes da atualidade.       Com foco em jornalismo, eleições e debate, é um espaço essencial para quem busca informação de qualidade.       Ao vivo de segunda a sexta-feira às 18h no nosso canal no Youtube.   https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #Flávio #Vorcaro #MentiuDeNovo #Podcast #Polêmica #Internet #Viral #Bastidores #Repercussão #Canais #Mídia #Exclusivo #Revelações #Engajamento #Atualidade #Debate #Conteúdo #Audiência #Notícias #AltaNaInternet

LBCT: SELUTION DeNovo: New Insights from the 12 Month Outcomes

Love the podcast? Send us a text!In this episode of Breast Cancer Conversations, host Laura Carfang speaks with Annick Pyfferoen about her experience being diagnosed with de novo metastatic breast cancer and navigating several lines of treatment including targeted therapy, chemotherapy, a clinical trial attempt involving tumor-infiltrating lymphocytes, Enhertu, and Xeloda. She speaks openly about what it felt like to experience rapid progression and why having a plan, even one that may change, helps her navigate uncertainty.This episode is a reminder that metastatic breast cancer care is not only about what is happening on scans. It is also about communication, side effect management, informed decision-making, emotional support, and helping people live as well as possible for as long as possible. Support the showListener FeedbackIf this episode resonated with you, we invite you to leave a review on Apple Podcasts or Spotify.You can also click the link in the show notes that says "Love this episode? Send us a text" to share feedback.Messages are completely anonymous.If you would like us to follow up directly, please include your email address in your message so we can respond.Latest News: Join our Mailing List - New content drops every Monday! Discover FREE programs, support groups, and resources from SurvivingBReastCancer.org! Become a Breast Cancer Conversations+ Member! Sign Up Now. Enjoying our content? Please consider supporting our work. 

Postura do presidente da República reflete caráter autocrático e desumano do petista.Você já leu uma notícia hoje e sentiu que já viveu esse momento antes?   Essa sensação de déjà Vu não é coincidência. No Brasil, o que é manchete hoje costuma ser o eco de decisões e fatos que analisamos meses, ou até anos atrás.   Para celebrar os 8 anos da Crusoé, decidimos enfrentar esse ciclo. Pegamos o que nasceu no digital e, pela primeira vez, transformamos em um registro físico, tátil e permanente.   Chegou a edição especial Crusoé impressa.   É um item colecionável, atemporal e limitado. Uma revista feita para quem gosta de ler com calma, longe das notificações do celular. Um exemplar para guardar sobre o que realmente importa na história recente do brasil.   Esta edição é um presente exclusivo para novos assinantes do Combo de 2 anos O Antagonista e Crusoé.   Utilize o cupom 8ANOSCRUSOE e acesse o link:   https://bit.ly/crusoe-edicao-impressa  Meio-Dia em Brasília traz as principais notícias e análises da política nacional direto   de Brasília.     Com apresentação de José Inácio Pilar e Wilson Lima, o programa aborda os temas mais quentes do cenário político e econômico do Brasil.     Com um olhar atento sobre política, notícias e economia, mantém o público bem informado.    Transmissão ao vivo de segunda a sexta-feira às 12h no nosso canal do Youtube.  https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #Lula, #Messias, #STF, #podcast, #política, #judiciário, #indicação, #governo, #notícia, #debate, #bastidores, #análise, #atualidades, #tribunal, #justiça, #direito, #planalto, #repercussão, #tendência, #retorno

This week, we revisit our conversation with Rich Ferrari. Rich is a seasoned healthcare entrepreneur and investor with a track record of building and scaling medical device and biotech companies. He is a Co-Founder of De Novo Ventures, a premier life sciences venture firm that managed $650M, and has helped raise over $1B in capital while contributing to nearly $1.8B in successful acquisitions. Most recently, Rich served as CEO and Chairman of PQ Bypass, leading to its $350M acquisition by Endologix. He has also led and exited multiple companies, including Cardiovascular Imaging Systems (acquired by Boston Scientific) and CardioThoracic Systems (acquired by Guidant), where he drove one of the fastest IPOs in medtech history. A prolific founder, Rich has co-founded several successful ventures acquired by major players like Johnson & Johnson, Abbott, and Medtronic. He currently serves on multiple boards, including Tenon Medical (NASDAQ: TNON), HeartBeam, and Medlumics. Rich holds a BS from Ashland University and an MBA from the University of South Florida, and is a recipient of the Mallinckrodt Award for Excellence in Medicine.

Esther Fischborn recebe Rafael Favero e Queki para analisar o empate com o Bahia em Salvador. Luís Castro muda escalação, deixa Gabriel Mec e Amuzu no banco e até sai na frente no placar, mas time é novamente amassado por rival e escapa de derrota graças a seu goleiro. Ouça!

No segundo episódio da série *Vale a Pena Ouvir de Novo*, revisitamos o mito de Sísifo, o astuto rei de Corinto que, segundo algumas tradições, poderia ser o verdadeiro pai de Ulisses. Excepcionalmente, este episódio conta com uma transcrição, disponível em noitesgregas.com.br – uma recompensa a todos os que apoiaram o podcast Noites Gregas nos últimos meses e ajudaram na migração do site para uma nova plataforma.Acesse noitesgregas.com.br/apoiar e tenha acesso a todo o conteúdo exclusivo.

Today we speak with Erik Weiner, CEO of de novo Portrait Bank. We discuss his banking background, why he started Portrait bank, the capital raise process, attracting talent, and building out a tech stack.  Click Here to Register for the 3rd Annual Elevate Banking Forum! The views, information, or opinions expressed during this show are solely those of the participants involved and do not necessarily represent those of SouthState Bank and its employees. SouthState Bank, N.A. - Member FDIC

Ex-governador mineiro publica nova série de vídeos de Os Intocáveis; sucesso, no entanto, tende a diminuir.Você já leu uma notícia hoje e sentiu que já viveu esse momento antes?   Essa sensação de déjà Vu não é coincidência. No Brasil, o que é manchete hoje costuma ser o eco de decisões e fatos que analisamos meses, ou até anos atrás.   Para celebrar os 8 anos da Crusoé, decidimos enfrentar esse ciclo. Pegamos o que nasceu no digital e, pela primeira vez, transformamos em um registro físico, tátil e permanente.   Chegou a edição especial Crusoé impressa.   É um item colecionável, atemporal e limitado. Uma revista feita para quem gosta de ler com calma, longe das notificações do celular. Um exemplar para guardar sobre o que realmente importa na história recente do brasil.   Esta edição é um presente exclusivo para novos assinantes do Combo de 2 anos O Antagonista e Crusoé.   Utilize o cupom 8ANOSCRUSOE e acesse o link:   https://bit.ly/crusoe-edicao-impressa  Meio-Dia em Brasília traz as principais notícias e análises da política nacional direto   de Brasília.     Com apresentação de José Inácio Pilar e Wilson Lima, o programa aborda os temas mais quentes do cenário político e econômico do Brasil.     Com um olhar atento sobre política, notícias e economia, mantém o público bem informado.    Transmissão ao vivo de segunda a sexta-feira às 12h no nosso canal do Youtube.  https://www.youtube.com/@OAntagonista   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #RomeuZema #OsIntocáveis #PolíticaMG #MinasGerais #DireitaBrasil #MarketingPolítico #Eleições2026 #Oposição #Zema #BastidoresPolíticos #AnálisePolítica #ComunicaçãoDigital #PodcastBrasil #MinasNoTopo #Liderança #DebatePolítico #Notícias #Estratégia #ConteúdoDigital #Brasil2026

See omnystudio.com/listener for privacy information.

Love the podcast? Send us a text!In this episode of Breast Cancer Conversations, Laura speaks with Virginia Rodriguez, who was diagnosed with stage 4 de novo metastatic breast cancer after experiencing progressive weakness, digestive issues, dehydration, and a dramatic decline in her ability to walk and function.Virginia shares what it was like to go from hiking the Camino de Santiago to struggling to climb the stairs in her own home, the emotional experience of finally receiving a diagnosis after months of unanswered symptoms, and how her care team identified breast cancer that had spread to multiple areas, including her brain, spine, liver, spleen, and bones.Virginia was placed on Verzenio, also known as abemaciclib, as part of her first line of treatment. Verzenio is an oral CDK4/6 inhibitor used in certain HR-positive, HER2-negative advanced or metastatic breast cancers, including in combination with endocrine therapy depending on a person's treatment history and clinical situationSupport the showListener FeedbackIf this episode resonated with you, we invite you to leave a review on Apple Podcasts or Spotify.You can also click the link in the show notes that says "Love this episode? Send us a text" to share feedback.Messages are completely anonymous.If you would like us to follow up directly, please include your email address in your message so we can respond.Latest News: Join our Mailing List - New content drops every Monday! Discover FREE programs, support groups, and resources from SurvivingBReastCancer.org! Become a Breast Cancer Conversations+ Member! Sign Up Now. Enjoying our content? Please consider supporting our work. 

A Apple vai trocar de CEO, o Marcus foi ali e voltou, e o Filipe fez um ultra vazamento.

A Apple vai trocar de CEO, o Marcus foi ali e voltou, e o Filipe fez um ultra vazamento.

Confira os destaques de Os Pingos nos Is desta quinta-feira (16):O senador Flávio Bolsonaro (PL-RJ) pode se tornar inelegível caso seja condenado no inquérito aberto pelo STF por suposta calúnia contra o presidente Lula (PT). Especialistas apontam que uma eventual condenação pode levar à suspensão dos direitos políticos, o que impediria sua candidatura. O senador Flávio Bolsonaro (PL-RJ) comenta as divergências dentro da direita e defende a construção de alianças para as eleições. Em entrevista à Jovem Pan, o filho do ex-presidente Jair Bolsonaro (PL) afirma que não pretende forçar apoios e destaca a importância da união para enfrentar adversários políticos. O comentarista Cristiano Beraldo critica as prioridades no debate sobre o senador Flávio Bolsonaro (PL-RJ), que pode se tornar inelegível após inquérito no STF por suposta calúnia contra o presidente Lula (PT). Para ele, o foco em postagens nas redes contrasta com os problemas reais de segurança enfrentados pela população brasileira. O pré-candidato à presidência Romeu Zema (Novo) apresenta propostas para uma reforma no Judiciário, incluindo mudanças no Supremo Tribunal Federal. Durante agenda em São Paulo, ele também defendeu medidas na segurança pública e criticou adversários como Flávio Bolsonaro (PL-RJ) e Ronaldo Caiado (União Brasil-GO). Ministros do Supremo Tribunal Federal discutem a criação de regras mais rígidas para as CPIs, limitando quebras de sigilo e acesso a provas. A proposta surge após polêmicas na CPI do Crime Organizado e aumenta a tensão entre o Judiciário e o Congresso Nacional. O senador Flávio Bolsonaro (PL-RJ) ironizou o presidente Lula (PT) ao afirmar que suas declarações públicas acabam ajudando sua pré-campanha. Em entrevista à Jovem Pan, ele disse que o adversário estaria “jogando a favor” ao expor suas posições. O Tribunal de Contas da União (TCU) revelou que a Força Aérea Brasileira realizou 111 voos com apenas um passageiro entre 2020 e 2024. A auditoria aponta que o governo poderia ter economizado mais de R$ 36 milhões com o uso de voos comerciais e destaca falhas no controle do transporte oficial.O ministro das Relações Institucionais, José Guimarães (PT), afirmou que o governo do presidente Lula (PT) pode aumentar o endividamento público para conter a alta de preços, especialmente de alimentos e combustíveis. As medidas em estudo já podem ultrapassar R$ 400 bilhões.Você confere essas e outras notícias em Os Pingos nos Is.

How is BindCraft, the automated pipeline for de novo protein binder design, changing the protein design industry? Martin Pacesa, assistant professor of pharmacology at the University of Zurich, joins The Chain to discuss how BindCraft is helping non-protein designers learn how to design proteins—and how the role of the protein designer will evolve. With host Chris Bahl, their conversation explores how BindCraft may help with drug development, its role in the democratization of tools and resources, and how to work more collaboratively with AI models. Pacesa will also be speaking at May's PEGS Summit in Boston.  Links from this episode:  AI Proteins UZH - Institute of Pharmacology and Toxicology  University of Zurich  

No episódio #599 do Narrativas, Madeleine Lacsko analisa as recentes falas do presidente Lula, questionando o tom machista de certas declarações e o silêncio — ou a seletividade — de setores do movimento feminista diante desses episódios.Um debate franco sobre coerência política, o peso das palavras no cargo mais alto do país e como as narrativas são moldadas na internet brasileira. Assuntos deste episódio:As declarações polêmicas de Lula e seus reflexos.O papel da militância feminista frente ao governo.A análise política ácida e necessária de Madeleine Lacsko.Narrativas analisa os acontecimentos do Brasil e do mundo sob diferentes perspectivas.     Com apresentação de #MadeleineLacsko, o programa desmonta discursos, expõe fake news e discute os impactos das narrativas na sociedade.     Abordando temas como geopolítica, comunicação e mídia, traz uma visão aprofundada   e esclarecedora sobre o mundo atual.     Ao vivo de segunda a sexta-feira às 17h.   Apoie o jornalismo independente. Assine O Antagonista e Crusoé com 10% via Pix ou Google Pay:   https://assine.oantagonista.com.br/   Siga O Antagonista no X:  https://x.com/o_antagonista   Acompanhe O Antagonista no canal do WhatsApp. Boletins diários, conteúdos exclusivos em vídeo e muito mais.  https://whatsapp.com/channel/0029Va2SurQHLHQbI5yJN344  Leia mais em www.oantagonista.com.br | www.crusoe.com.br #Lula #Machismo #Feminismo #MadeleineLacsko #Narrativas #Política #Brasil #Esquerda #DireitosDasMulheres #Jornalismo #Opinião #PodcastBrasil #Debate #Atualidades #Polêmica #GovernoLula #Crítica #Sociedade #MulheresNaPolitica #Democracia

Estamos lançando hoje a série “Vale a Pena Ouvir de Novo”, em que vamos reeditar e repostar quatro episódios antigos da Hora do Oráculo. A ideia é revisitar histórias de personagens que reaparecem neste momento de transição entre o fim da Saga de Troia e o início da Odisseia. Começamos com Cassandra, filha de Príamo, figura poderosíssima e de destino trágico, morta por Clitemnestra no episódio anterior.- NOVIDADE: A transcrição deste episódio está disponível na área exclusiva do apoiador- MUITO OBRIGADO: A série também é um agradecimento a todos que estão nos apoiando na migração da nossa plataforma, que reúne episódios, PDFs e aulas produzidos ao longo desses anos.- APOIE O NOITES GREGAS: Se você quiser ajudar, é possível apoiar em ⁠https://noitesgregas.com.br/apoiar⁠ ou fazer um pix de qualquer valor para ⁠noitesgregas@gmail.com⁠.

Caio Blinder, integrante do Manhattan Connection, com passagens por O Globo, Folha de S.Paulo, VEJA, Jovem Pan e BBC Brasil, analisa e comenta as relações internacionais, no Jornal Eldorado, às 4ªs e 6ªs feiras, 8h15.See omnystudio.com/listener for privacy information.

In this episode, host Etienne Nichols sits down with Dr. Adam Saltman, Chief Medical Officer at NAMSA, to explore the treacherous "valley of death" that exists between a medical device prototype and the patient. With a unique "triple threat" perspective as a cardiothoracic surgeon, former FDA official, and industry consultant, Dr. Saltman reveals why technical brilliance often fails in the face of commercial reality.The conversation dives deep into the common pitfalls of early-stage startups, specifically the tendency to develop technology in a "tech echo chamber" without validating the unmet clinical need. Dr. Saltman shares a sobering story of a company that achieved regulatory authorization and reimbursement only to find that no one wanted to buy their product because it solved a problem clinicians didn't have.Finally, the discussion shifts to the evolving landscape of AI in healthcare. Dr. Saltman warns against "automation bias" and emphasizes that regulators and clinicians are no longer satisfied with "black box" explanations. Whether it's navigating FDA guidance or choosing between a 510(k) and a De Novo pathway, the takeaway is clear: start with the end user in mind and validate every hypothesis with real-world clinical perspective.Key Timestamps[00:01:45] Introducing Dr. Adam Saltman: The surgeon, regulator, and consultant perspective.[00:03:10] The #1 Mistake: Building a product that doesn't address an actual unmet clinical need.[00:05:40] The Echo Chamber: Why engineers must look beyond their own circles for product validation.[00:06:50] The CFO vs. The Surgeon: A cautionary tale about who actually makes the purchasing decisions in a hospital.[00:09:40] Staying Current: How to manually and digitally track the constant stream of FDA guidance documents.[00:11:45] AI in MedTech: Moving from "black box" algorithms to transparent, explainable technology.[00:13:30] The X-Ray Failure: A real-world example of AI predicting mortality based on patient location rather than clinical data.[00:15:20] Automation Bias: Why you should treat AI as an assistant, not a replacement.[00:18:15] Marketing vs. Utility: The "Billboard Effect" of surgical robots and AI features.[00:20:00] Signs of Success: How Dr. Saltman identifies startups that are likely to succeed versus those "wasting" capital.[00:23:10] Calling the Baby Ugly: The necessity of pivot-readiness and adult influence in startup management.[00:25:30] The 510(k) Trap: Why the fastest regulatory path might be your biggest commercial hurdle.Quotes"You really need to start with the end in mind and test that hypothesis. Get out of the office and go out there and talk to people and really confirm that." - Dr. Saltman"This is my assistant, not my replacement." - Dr. SaltmanTakeawaysValidate the Unmet Need: Before investing in R&D, ensure your target customer actually sees a need for the product. Technical viability does not equal market demand.Avoid the 510(k) Trap: Opting for the easiest regulatory path may pigeonhole your device into low reimbursement codes by labeling it as "the same" as existing technology.Combat Automation Bias: Never assume an AI or automated system is 100% correct. Maintain a critical eye and perform regular "smell tests" on AI-generated outputs.Engage Clinical Input Early: It is almost impossible to get professional clinical input too early, but it is very easy to seek it too late. Consider fractional clinical leadership to save costs.Identify All Stakeholders: Your user (the surgeon or nurse) is often not the purchaser (the CFO). Your evidence strategy must satisfy both.ReferencesZotero: A free reference manager Dr. Saltman uses to track and tag FDA guidance documents.The Founder's Dilemma: A book referenced regarding the challenges of early-stage startup management and decision-making.Etienne Nichols' LinkedIn: Connect with Etienne here.MedTech 101 Section: The 510(k) vs. De NovoThink of a 510(k) like a "Me Too" application. You are telling the FDA, "My device is just like this other one already on the market (the predicate)." It's usually faster and cheaper. A De Novo is for "New" territory—devices that are low-to-moderate risk but don't have a direct twin already on the market. While 510(k) is the path of least resistance, it can be a "trap" because it makes it harder to argue that your device is unique enough to deserve a higher price or better insurance coverage.Feedback Call-to-ActionWe want to hear from you! Do you have a MedTech success story or a regulatory hurdle you're currently facing? Send your feedback, reviews, and topic suggestions to podcast@greenlight.guru. We read every email and love providing personalized responses to our community of innovators.SponsorsThis episode is brought to you by Greenlight Guru. When navigating the "valley of death" between prototype and patient, you need a robust ecosystem to manage your data. Greenlight Guru offers industry-leading QMS (Quality Management Software) to keep your compliance on track and EDC (Electronic Data Capture) solutions to ensure your clinical evidence is ironclad. Whether you're avoiding the 510(k) trap or preparing for a De Novo submission, Greenlight Guru helps you close the gap with confidence.

Sobre pelegos e assassinos. *********************** Melhor forma de ajudar o Medo e Delírio? Pix recorrente no medoedelirioembrasilia@gmail.com *AGENDA* .11 de abril, sábado, 16h SÃO PAULO Lançamento do livro “Juízo Final” Megafauna do Copan .16 de abril, quinta, 19h BRASÍLIA Lançamento do livro “Juízo Final”! Paradeiro Café .18 de abril, sábado, 20h BRASÍLIA Festa do Medo e Delírio na Infinu! https://shotgun.live/pt-br/events/isso-e-jazz-22 .25 de abril, sábado, 16h RIO DE JANEIRO Lançamento do livro “Juízo Final”! Livraria Janela, Laranjeiras .26 de maio, terça, 19h BELO HORIZONTE Lançamento do livro “Juízo Final”! Livraria JenipapoQuer anunciar no Medo e Delírio, escreve pra gente no medoedelirioembrasilia@gmail.com O post II – 2026.22 – (SEM TRADUÇÃO) E lá vem os lesa-pátria de novo… apareceu primeiro em Central 3.

Sobre pelegos e assassinos. *********************** Melhor forma de ajudar o Medo e Delírio? Pix recorrente no medoedelirioembrasilia@gmail.com *AGENDA* .11 de abril, sábado, 16h SÃO PAULO Lançamento do livro “Juízo Final” Megafauna do Copan .16 de abril, quinta, 19h BRASÍLIA Lançamento do livro “Juízo Final”! Paradeiro Café .18 de abril, sábado, 20h BRASÍLIA Festa do Medo e Delírio na Infinu! https://shotgun.live/pt-br/events/isso-e-jazz-22 .25 de abril, sábado, 16h RIO DE JANEIRO Lançamento do livro “Juízo Final”! Livraria Janela, Laranjeiras .26 de maio, terça, 19h BELO HORIZONTE Lançamento do livro “Juízo Final”! Livraria JenipapoQuer anunciar no Medo e Delírio, escreve pra gente no medoedelirioembrasilia@gmail.com O post II – 2026.22 – (COM TRADUÇÃO) E lá vem os lesa-pátria de novo… apareceu primeiro em Central 3.

O programa desta semana, excepcionalmente na terça-feira, falará sobre o saldo do Brasil na data Fifa de março, a última antes da convocação para a Copa. Quem ganhou e quem perdeu espaço na lista final de Carlo Ancelotti? Como está a preparação do time? Também falamos sobre os classificados à Copa do Mundo na repescagem.SEJA MEMBRO! Seu apoio é fundamental para que o Meiocampo continue existindo e possa fazer mais. Seja membro aqui pelo Youtube! Se você ouve via podcast, clique no link na descrição para ser membro! https://www.youtube.com/channel/UCSKkF7ziXfmfjMxe9uhVyHw/joinNEWSLETTER! Nossa newsletter chega toda sexta aberta a todos com nossos textos sobre o que rolou na semana, e às terças com conteúdo apenas para assinantes: https://newsletter.meiocampo.net/Conheça o canal do Bonsa sobre Football Manager, BonsaFM: https://www.youtube.com/@BonsaFMConheça o canal do Lobo sobre games, o Próxima Fase: https://www.youtube.com/@Proxima_FaseConheça o canal de Leandro Iamin sobre a seleção brasileira, o Sarriá: https://www.youtube.com/@SarriaBrasil