Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Featured Stories

Flat-Lining US FDA: Failure To Invest May Have Consequences

Old habits die hard when it comes to funding the FDA. When the agency is doing things well, it doesn’t get the money it needs to keep up the momentum. 

Legislation User Fees FDA

US FDA May See Second Straight Year of Non-User Fee Funding Cuts From Congress

The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle. 

FDA Legislation Politics

Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Digital Health Business Strategies Commercial

Radiologists Ask For AI-Focused Reimbursement Pathway

The pathway, which would be separate from breakthrough device reimbursement, would allow new AI technology to be reimbursed based on “clinical value and public stakeholder engagement.”

Medicare Artificial Intelligence Government Payers

Spotlight On Conferences

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

Europe EU

Medtech Insight Podcasts


This Episode:

Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
 

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

More Podcasts

Global Device Regulation

AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

Europe EU

3 Deaths Linked To Latest Teleflex Catheter Recall

Teleflex is recalling thousands of intra-aortic balloon catheter kits that are used during cardiac procedures and to treat complications from heart failure. This is the latest in a series of recalls from Teleflex and its subsidiary Arrow International.

FDA Recalls

Industry Finds Innovative Revenue Streams For Digital Therapeutics

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

DTA Digital Health

Despite Noisy Debut, Report Finds Impact Of OTC Hearing Aids Still Muted

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

FDA OTC Devices
Digital Health

Industry Finds Innovative Revenue Streams For Digital Therapeutics

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

DTA Digital Health

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

News We're Watching Approvals

US, UK And Canada Collaborate On Transparency Principles For Devices Using Machine Learning

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

FDA Regulation

DTX Companies Find New Niche As Complement To Standard Of Care

Digital therapeutics aren’t going away anytime soon, but they are positioning themselves as a complement to traditional therapies.

Digital Health DTA
See All
Interviews

AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

Europe EU

Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Digital Health Business Strategies

Nexsen Targets Clinical And At-Home Markets With Rapid Diagnostic For GBS Infection

Australia-based Nexsen BioTech is developing StrepSure, a rapid lateral flow test for detecting Group B Streptococcus (GBS) infection in pregnant women. Designed to provide results within 15 minutes, with the potential to save "millions of babies’ lives,” StrepSure will be assessed in a 5,000-patient clinical trial targeted for summer 2025, which will support Australia and US submissions for market authorization. Thomas Hanly, Nexsen managing director, discusses. 

Europe United Kingdom

Why Notified Bodies Are Now The Focus Of Centralized Oversight Efforts

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

Europe EU
Podcasts

Medtech Connect Episode 15: Digital Trust

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

Cybersecurity Digital Health

Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.   

Digital Health Approvals

Medtech Connect 14: Live From HIMSS

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.

Medtech Connect Artificial Intelligence

Digital Health Roundup: Impact Of EU’s AI Act On Device Makers; Verily's Andrew Trister’s Vision For Personal AI Agent

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.

Digital Health Roundup Artificial Intelligence
See All
Recent Stories

AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

3 Deaths Linked To Latest Teleflex Catheter Recall

Teleflex is recalling thousands of intra-aortic balloon catheter kits that are used during cardiac procedures and to treat complications from heart failure. This is the latest in a series of recalls from Teleflex and its subsidiary Arrow International.

Industry Finds Innovative Revenue Streams For Digital Therapeutics

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

Despite Noisy Debut, Report Finds Impact Of OTC Hearing Aids Still Muted

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

US, UK And Canada Collaborate On Transparency Principles For Devices Using Machine Learning

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

DTX Companies Find New Niche As Complement To Standard Of Care

Digital therapeutics aren’t going away anytime soon, but they are positioning themselves as a complement to traditional therapies.

Nexsen Targets Clinical And At-Home Markets With Rapid Diagnostic For GBS Infection

Australia-based Nexsen BioTech is developing StrepSure, a rapid lateral flow test for detecting Group B Streptococcus (GBS) infection in pregnant women. Designed to provide results within 15 minutes, with the potential to save "millions of babies’ lives,” StrepSure will be assessed in a 5,000-patient clinical trial targeted for summer 2025, which will support Australia and US submissions for market authorization. Thomas Hanly, Nexsen managing director, discusses. 

Why Notified Bodies Are Now The Focus Of Centralized Oversight Efforts

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

Therapeutic Endoscopy: ‘We’re At The Start Of What’s Possible’

In the emerging field of therapeutic endoscopy, Creo Medical’s Speedboat devices are advancing minimally invasive treatment by combining advanced bipolar radiofrequency and super high frequency microwave energy in a single device, says CTO and founder Chris Hancock.

ADDF Leaders Discuss Future Strategies In Alzheimer’s Research And Crucial Role Of Diagnostic Markers

Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

UsernamePublicRestriction

Register