Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.

The sudden halt to grants and health agency communications is causing stress for the rare disease advocacy community, speakers said at a recent rare disease symposium.

While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.

The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.

Measures for reporting interruption of supply or discontinuation of devices in Europe were rushed into the Medical Device Regulation, a German law firm claims, leading to the need for a stricter interpretation.

The Dermanostic app is in the spotlight again as its recent action has prompted a German regional court to believe it no longer falls foul of a ruling recently made by a higher regional court.

The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.

The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.

An innovative patient monitoring system developed by Danish physicians sends vital signs data directly to nurses, allowing them to keep tabs on patients without being in the room.

During CES 2025, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis to identify the biggest trends in digital health and solutions poised to transform the future of health care. Key trends included empowering consumers with actionable health data, the rising investment in specialized areas such as women’s health, and more companies pursuing regulatory clearance for health products.

LFH Regulatory managing director and founder Laura Friedl-Hirst tells Medtech Insight what was piquing the interest of medtech companies visiting her company’s stand at Medica 2024.

In this second roundup of innovative technologies seen or demoed at CES 2025, Medtech Insight tunes into heartbeat-listening earbuds, vision aids for people with macular degeneration, UTI-detecting toilets, non-invasive injection devices, hot flash-cooling wristband, mobility-aiding smart shoes, and robotic aids for cerebral palsy.