This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.

Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The DHCoE’s new page provides a one-stop-shop for frequently asked digital health policy questions.

The World Health Organization has published a report detailing the barriers to digital health’s adoption across the territories in which it operates.

The two tech companies – one software giant, the other focused on oncology – will work together on what will likely be the largest artificial intelligence model of its kind.

Medtech Insight talked to GreyBird Ventures founder Tom Miller about his investment philosophy, ethical filter in selecting diagnostics-focused start-ups, the future of diagnostics such as at-home home-testing and AI, and his life-long passion for motocross racing. 

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The Swedish company has developed a proprietary method of personalizing venous grafts, and plans to bring it – alongside some other products – to the market.

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 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 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.

This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.

The Paris-based start-up has picked up a CE mark for the latest generation of its Maestro system, a tool designed to make laparoscopic surgery easier and safer.

Relievant’s Intracept intraosseous nerve ablation system is the only FDA-cleared neuromodulation device indicated to treat vertebrogenic pain. Boston Scientific will pay $850m for Relievant, plus undisclosed milestone payments over the next three years.

Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.

The UK-based company has just raised $165m support the ongoing commercialization of the Versius robotic platform.

Inaugural artificial intelligence recommendations from NICE on radiotherapy contouring should allow clinicians to spend more time with patients and on complex cases where AI is not an option. But large language models are not appropriate in all cases, cautions Adrian Sutherland, principal healthcare architect at Endava consultancy.

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The DHCoE’s new page provides a one-stop-shop for frequently asked digital health policy questions.