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Featured Stories

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.

Trade Policy Asia Pacific Durable Medical Equipment

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.

BIO Neurology Innovation

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 France

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.

Innovation Cancer Gastrointestinal

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

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

Deloitte Tackles Pros and Cons of Europe For Medtech

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

Europe Market Intelligence

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development
Digital Health

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

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development

What’s New In Digital Therapeutics? Investment Strategies, Reimbursement And More From DTA Annual Summit Day 1

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

DTA Digital Health
See All
Interviews

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

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.

Innovation Cancer

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.

BIO Neurology
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

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. 

Deloitte Tackles Pros and Cons of Europe For Medtech

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Oliver Bisazza Warns That EU’s Innovation Issues May Create More Reliance On Medtech Imports

Innovation has been hindered in the EU by the costs and complexities of compliance, including in the medtech sector. Bisazza looks at how high-level, multi-sectoral moves are underway to create a more innovation-friendly environment.

Physician And myTomorrows CEO Discusses FDA’s New Program To Advance Clinical Trial Diversity

The US FDA recently announced a new initiative aimed at improving access to cancer trials among traditionally underserved populations. myTomorrows CEO Michel van Harten talked to Medtech Insight about how the agency’s plan might reshape the landscape of clinical trials going forward.

Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

Amendment To MDR May Be First Legislative Proposal Of New European Commission

How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.

What’s New In Digital Therapeutics? Investment Strategies, Reimbursement And More From DTA Annual Summit Day 1

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

News We’re Watching: Medtronic Recall, More Chinese Syringe Woes, Surgical Robot Clearance

This week, Medline announced recalls of tracheal tubes; Eko Health raised $41m in Series D funding; and the US FDA announced participation in collaborative communities focused on brain-computer interface devices and more.

Carthera Aims To Break Barriers In Brain Cancer Treatment With BBB-Crossing Device

The France-based, clinical-stage medtech has enrolled first patients in a pivotal trial to evaluate overall survival in glioblastoma patients using its implanted SonoCloud-9 ultrasound device combined with a chemotherapy. If successful, it will become the first technology to optimize drug delivery by opening the blood-brain barrier.

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