Medtech Insight

Medtech manufacturers, hospitals and EU trade bodies are pressing USTR to exempt medical devices from proposed Section 301 forced-labor tariffs, warning the levies would raise healthcare costs, disrupt fragile supply chains, and push production offshore rather than reshore it. Under the proposed framework, 46 economies would face a 12.5% tariff rate, while 14 economies viewed as having relatively stronger forced-labor import prohibition regimes would be subject to a 10% rate.

AceJan Capital has agreed to pull its five-minute C. diff kill-time claim after advertising self-regulatory group NAD found the company’s lab data insufficient to support the assertion under ordinary hospital-use conditions.

The US FDA has approved a novel dual-energy catheter ablation platform that enables electrophysiologists to deliver both pulsed field and radiofrequency energy through a single catheter. The platform provides physicians with greater flexibility to tailor ablation strategies based on patient anatomy. (Shutterstock) Johnson & Johnson has reached a major milestone for its cardiac ablation platform, which could expand treatment options for atrial fibrillation (AFib).

Physicians across six countries are already looking at consumer wearable data — but almost none have made it part of how they practice. A new AMA survey of 2,222 doctors finds the barriers are structural: no reimbursement, no validated workflows, and persistent liability concerns. The survey covered lifestyle wearables such as the Apple Watch, Oura Ring, WHOOP, Garmin and Fitbit devices, along with over-the-counter biosensors including Dexcom Stelo and Abbott Lingo.

Key Takeaways Article 5 of the EU AI Act categorically bans several AI practices – such as subliminal manipulation and emotional inference – that could touch on some forms of medtech. An often-overlooked article of the EU AI Act bans certain uses of AI that the Act deems to present “unacceptable...

News Executive Summary European Commission acts on call from industry for more guidance from notified bodies around innovation. Existing Subscriber? Sign in to continue reading. New to Medtech Insight? Start a free trial today!

Analysis Executive Summary At this year’s LSX Nordic conference, experts from Baxter, Philips and Novo Nordisk described key attributes they look for when selecting companies for partnerships or acquisitions and provided advice to founders on how and when to start positioning their start-ups for such opportunities. Source: LSX/Informa Connect Existing Subscriber? Sign in to continue reading. New to Medtech Insight? Start a free trial today!

News Executive Summary Industry experts believe the future of medtech will be centered around patients and their data. To thrive, medtech companies must integrate themselves more organically in the patient continuum and adopt more of a Big Tech mindset in order to meet users' evolving expectations. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Medtech Insight? Start a free trial today!

Analysis Executive Summary Achieving a balance between regulatory controls and promoting innovation is proving one of the biggest challenges that the EU is facing since the implementation of the MDR and IVDR. But there are ways through. Existing Subscriber? Sign in to continue reading. New to Medtech Insight? Start a free trial today!

News Executive Summary This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device. Source: Medtech Insight Existing Subscriber? Sign in to continue reading. New to Medtech Insight? Start a free trial today!