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 episode of new podcast series Medtech Connect, Medtech Insight’s regulatory writer for Europe, Eliza Slawther, interviews Alexander Olbrechts, director for digital health at the European trade body MedTech Europe, to find out more about the proposed European Health Data Space initiative and what it means for the medical device industry.

In the first episode of new podcast series Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Foley and Lardner partner Kyle Faget about the complexities behind regulating software as a medical device (SaMD). Many companies are unsure if their software is even regulated by the FDA, let alone how to go about the clearance process. From managing cybersecurity risks to navigating digital health policy, Faget does it all, and she gives us insight into the regulatory landscape of SaMD in this month’s episode.

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 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.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses conference highlights from SXSW and LSI while Barnaby Pickering talks about his coverage on voice biomarkers. Hannah Daniel discusses BetterHelp’s return of $7.8m to customers to settle with FTC for sharing health data.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights how Alife Health is using its AI-based platform for IVF to increase chances for successful pregnancies while Barnaby Pickering discusses how AI Medical Technology is using AI to detect melanoma. Reed Miller talks about weight-loss device maker Allurion Technologies’ signed SPAC deal.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.

In this month’s Digital Health Roundup, Medtech Insight’s Reed Miller offers a recap from the recent TCT 2022 meeting and talks about Butterfly Network’s expansion into Africa while Marion Webb highlights her interview with Aidoc’s CEO Elad Walach discussing plans for the AI-based software company.

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.

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.

In the EU, the amending regulation to the MDR is not creating as many waves as the amending regulation to the IVDR did. The reasons are many.  But this is good news for the medtech industry, as is a general uptick in purposeful communication.

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.

Against a globally tough environment, recruitment for EU medtech regulatory roles slowed down. Elemed’s Elena Kyria explains what is shaping talent hiring now there are signs of an uptick and how job seekers and recruiters can best position themselves

There are still several missing key elements needed for the implementation of the EU’s IVD Regulation. Three key experts focused on how to move forward, particularly with the highest risk, class D, IVDs.

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 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.