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Featured Stories

Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice

A US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.

Regulation Advisory Committees Drug Safety

Postmarket Surveillance Continues To Challenge AI/ML Device Regulators

Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.

Artificial Intelligence Regulation FDA

Getting Personal With Tom Miller: CEO Turned VC On Ethical Bets In Diagnostics

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. 

Exec Chats Diagnostics Financing

Class I Recall For Medline’s Saline Solution Packs

Medline Industries has issued a recall of some of its saline solution products for being non-sterile. The US FDA has designated the recall class I.

FDA Recalls Regulation

Spotlight On Medtech Insight Podcasts

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

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.

Digital Health Artificial Intelligence

Medtech Insight Podcasts

This Episode:

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

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Global Device Regulation

News We're Watching: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients

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.

Commercial Regulation

Q&A: Allyson Mullen On ‘Uncharted Waters’ Of Breakthrough Pathway

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.

FDA Regulation

Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study

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.

Europe EU

New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears

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.

Guidance Documents FDA
Digital Health

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

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.

Diversity & Inclusion Business Strategies

Digital Health Center Of Excellence Publishes Policy FAQs

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

Digital Health FDA

As Digital Health Races Forward, Governments’ Understanding Of It May Be Stalling

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

Digital Health Legislation

Minute Insight: Paige Strikes It Big With Microsoft Partnership

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.

Minute Insights Artificial Intelligence
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Interviews

Getting Personal With Tom Miller: CEO Turned VC On Ethical Bets In Diagnostics

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. 

Exec Chats Diagnostics

Q&A: Allyson Mullen On ‘Uncharted Waters’ Of Breakthrough Pathway

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.

FDA Regulation

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

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.

Diversity & Inclusion Business Strategies

VERIGRAFT Is Taking A Fresh Approach To Personalized Tissue Grafting

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

Medical Device Diabetic Care
Podcasts

Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health

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.

Digital Health Diagnostics

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

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.

Digital Health Artificial Intelligence

Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel

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.

EU Europe

Medtech Connect Episode 8: Exploring Regulatory Differences Between The EU And US

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.

Medtech Connect Digital Health
See All
Recent Stories

News We're Watching: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients

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.

Commercial Regulation

Q&A: Allyson Mullen On ‘Uncharted Waters’ Of Breakthrough Pathway

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.

FDA Regulation

Minute Insight: Maestro Cues The Music With CE Mark For Moon Surgical

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.

Minute Insights Robotic Surgery

Boston Scientific Puts Charge In Neuromodulation Business By Acquiring Relievant

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.

M & A Neurology

Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study

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.

Europe EU

Minute Insight: 15,000 Surgeries And More Funding For CMR Surgical

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

Robotic Surgery Financing

AI Medical Imaging And Radiotherapy First For UK’s NICE

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.

Artificial Intelligence Medical Device

New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears

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.

Guidance Documents FDA

Representatives Press CMS On Coverage Of Innovative Devices

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.

Policy Legislation

Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway

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.

Europe United Kingdom

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

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.

Diversity & Inclusion Business Strategies

Digital Health Center Of Excellence Publishes Policy FAQs

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

Digital Health FDA
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