Featured Stories

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.

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.

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.

Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR
The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?
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.
Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel
Medtech Connect Episode 8: Exploring Regulatory Differences Between The EU And US
Digital Health Roundup: What’s Hot On Investment; Diabetes; AI
Cardio Conversations: 'Trials, Trials, Trials!' Volta Has Big Ambitions For AI In EP
Latest News
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

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.

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.

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.

Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR
The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.
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.

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.

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.

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.
Interviews

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.

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.

Spinning Around – One Company's Bid To Diagnostic-ify The Metabolism
Lifespin is working on tools to characterize a patient’s metabolism and provide more detailed information about a disease.

Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program
Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.
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 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.

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.

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.
Recent Stories

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.

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.

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.

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.

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.

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.

Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR
The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.

FDA Finalizes Voluntary Improvement Program Guidance Document
The US FDA has finalized a guidance document on the Voluntary Improvement Program, which aims to help manufacturers continuously improve quality and compliance.

Federal Court Rejects Motion To Dismiss Case In Genomics Patent Infringement Suit
Parse Biosciences’ motion to dismiss a patent infringement case has been rejected by a US District Court.

Califf Hires New US FDA Senior Advisor, But Duties Seem Vague
As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.

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.

Are GLP-1 Major Threat To The Insulin Delivery Tech Market?
A small scale study has indicated that GLP-1 agonists could restore normal HbA1c levels in type I diabetics. This therapy could be a huge step forward for the treatment of this chronic disease if this benefit is shown in larger studies.
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