In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements. 

Medtech Insight regulatory reporter Hannah Daniel speaks to Sanjay Voleti, AliveCor’s chief business officer, about his company’s patent infringement case against Apple and what it’s like to take on a tech giant over intellectual property.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to King & Spalding’s Eric Henry about the year’s most influential digital health regulations in the US and EU, and what we may have missed in all the excitement.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations. If you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.

In this episode of Medtech Connect, Medtech Insight spoke to three decentralized clinical trial experts at Hogan Lovells: partner Kristin Zielinski Duggan, partner Blake Wilson and associate Stephanie Agu. We discussed the ins and outs of the draft FDA guidance document, what pieces of the guidance still might need clarification and how they expect to see the industry change as DCTs become mainstream.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials, and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations, and Kaminski shares a personal story about why the safety of medical devices matters so much to him.

In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed.

In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews, Kelliann Payne, partner at Hogan Lovells. Payne advises artificial intelligence (AI) medical device manufacturers with premarket submissions and helps them navigate the complicated regulatory landscape. She laid out the current FDA regulations for AI medical devices and explained the importance of predetermined change control plans, a new cyber regulation from the Consolidated Appropriations Act of 2023.

In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Scott Trevino, senior vice president of cybersecurity at TRIMEDX, about the new cybersecurity oversight given to the FDA as a part of the Omnibus Appropriations bill passed in December.  

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb looks back at ADA 2023 highlights and her interviews with diabetes company execs. Reed Miller discusses his Cardio Conversation with Volta Medical and Hannah Daniel discusses the FDA’s Clinical Decision Support Software final guidance.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb and Hannah Daniel discuss highlights from their DTA Summit coverage in Washington. Reed Miller talked to Frank Chan, the president of Medtronic’s Patient Monitoring, about plans for their patient monitoring as an independent company and Bayer AG’s new business unit focusing on digital health.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials, and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations, and Kaminski shares a personal story about why the safety of medical devices matters so much to him.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm, and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.

iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.

In this edition of Cardio Conversations, Medtech Insight editor Reed Miller talked to Robert Chisena, the co-founder and CTO of AVS (Amplitude Vascular Systems) where leads research and product development. He talked about his company's novel interventional technology for calcified peripheral arterial disease and how the company came together despite the pandemic.

In this edition of Cardio Conversations, Medtech Insight editor Reed Miller talked to Théophile Mohr Durdez, the CEO and co-founder of Volta Medical, a Marseille-based company applying artificial intelligence to electrophysiology. Volta has raised over €70m and is sponsoring the TAILORED AF trial to show that its software can make atrial fibrillation ablation more effective.

Quentin Blackford, CEO of iRhythm, talked to Medtech Insight about his company’s plans to bring its Zio long-term cardiac monitoring platform to more patients by building its evidence base and marketing in more countries outside the US.

Rob Krummen, the CEO of Vektor Medical, talked to Medtech Insight about Vektor’s vMap computational modeling system that relies on 12-lead electrocardiography data to identify cardiac arrhythmias.

In this special extra episode of Medtech Insight's podcast series on cardiovascular technology, editor Reed Miller talked to Vish Charan, the divisional vice president of product development in Abbott's cardiac rhythm management division.

In this episode of Medtech Insight’s new podcast series focused on cardiovascular technology, editor Reed Miller talked to Christopher Piorkowski, Abbott's chief medical officer for electrophysiology.

In the first episode of Medtech Insight’s new podcast series focused on cardiovascular technology, editor Reed Miller talks to Steven Mickelsen, one of the founders of Farapulse and Field Medical, about pulsed field ablation, an emerging technology that is changing electrophysiology.

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Tune in to this one-off podcast feature discussing the state-of-play in the diagnostics sector, with guests from ImmunExpress, Lucid Diagnostics and ChromaCode. 

Medtech SME Pennine Healthcare has a range of business challenges to navigate, but compliance with heightened environmental sustainability standards has rapidly risen up its list of priorities.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.

In this special podcast, Medtech Insight managing editor Elizabeth Orr talks to consultant Steve Silverman about the FDA’s current position on real-world evidence and real-world data, as well as how manufacturers can best put the evidence types to use.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

The European medical device database, Eudamed, is arguably the missing lynchpin in the implementation of the EU’s Medical Device and IVD Regulations. Medtech Insight spoke with Lionel Tussau of atrify to discover what companies need to know now and how actors should be preparing.