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Featured Stories

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 Policy

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.

Legal Issues Intellectual Property Regulation

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?

Europe EU Medical Device

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.

EU Europe Medical Device

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.

More Podcasts

Global Device 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

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
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

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

Click Therapeutics And Indivior Collaborate On Prescription Digital Therapeutics In Substance Use Disorder

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

Artificial Intelligence Behavioral Health
See All
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.

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

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.

In Vitro Diagnostics Metabolic

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.

FDA Regulation
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

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

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

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.

Regulation Compliance

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.

FDA Leadership

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

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.

Diabetic Care Metabolic

AdvaMed Proposes Comprehensive Strategy for CMS To Encourage Access to AI and Software

AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.

Medicare Regulation
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