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 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 month’s Digital Health Roundup, Medtech Insight’s Reed Miller talks about Biotronik’s and AliveCor’s partnership, Marion Webb profiles three agetech companies, and Barnaby Pickering talks Swiss medtech awards and smart hospitals.

In this month’s Digital Health roundup, Medtech Insight’s Marion Webb discusses her deep-dive article on menopause with leading experts in this rising industry and Barnaby Pickering highlights UK-based Proximie, which developed a web-based platform that allows surgeons and other clinical experts to collaborate virtually in the operating suite. The company recently raised $80m in a series C round.

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights AI trends in medtech, Exec Chats with iRhythm and medical robotics authority Moshe Shoham, and key FDA updates.

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights conference highlights from HIMSS, AAOS, Sensors Summit and legislative telehealth news.

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.

In this roundup feature focusing on developments in digital health, Medtech Insight highlights interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements from November.

In this roundup feature focusing on the developments in digital health, we highlight the key news and announcements from July.

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.

“Sell the problem your technology can solve,” Michael Branagan-Harris, CEO of Device Access UK Consultancy, advises medtech companies targeting a launch on the UK market. In this podcast with Medtech Insight, he explains how companies with awareness should grasp the new opportunities soon to be available following changes to device access and regulation in Great Britain.

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 special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes' broad range of orthopedic implants and tools to meet the demand of an aging population.

Medtech Insight sat down with Brittany Barreto, CEO of FemHealth Insights, who participated in a panel discussion at SXSW 2023 on the $1t femtech industry, to talk about her journey to becoming a women’s health care champion.

Germany is introducing a new system of paying for inpatient care, whereby funds will be allocated both to diagnosis related groups and to a provisional pot from which funds will be distributed according to the type of care delivered. In this podcast with Medtech Insight, Gabriel Flemming of Germany Trade & Invest explains what it all means for medtech.

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 new series titled Getting Personal, we talk to new and veteran senior executives about their journeys to corporate leadership, their motivations, passions, and the peaks and valleys of running a medtech company. Medtech Insight talked with Ken Stein, Boston Scientific’s global chief medical officer about his own diagnosis with atrial fibrillation and advice for others living with the disease, innovative technologies in development at Boston Scientific, and some of his proudest and more challenging times on the job, as well as his advice for other physicians who are contemplating a move into the corporate world.

Listen up! In this episode of Medtech Monthly, Eargo CEO Christian Gormsen discusses the newly created OTC category for hearing aids. 

Medtech Insight’s annual listing of the leading medtech companies by revenues is now available on the Medtech Insight website.

In this edition of the Medtech Monthly podcast, Medtech Insight editor Reed Miller talks to UK-based reporter Barnaby Pickering to get a overview of the highly competitive diabetes tech and future of this dynamic, consumer-centric market.

This second Medtech Insight podcast on the basics of EU medical device regulation looks at the main EU organizations involved in medtech regulation, the four medical device risk classes, and the role of the key regulatory documents.

In this episode of Report Digest, UK-based reporter Barnaby Pickering speaks to analyst Carrie Neptune about three Meddevicetracker reports on drug delivery technology.