Companies Will Face Increased Regulatory Challenges In 2025, Pair Of Reports Say

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.

Costly ransomware attacks, evolving cybersecurity guidance documents, the rise of AI-powered medical devices, and the growing acceptance of at-home health care thanks to advancements in digital health are just some of the regulatory challenges facing medtech firms as they move toward next year.

More from Medtech Insight

Get A Grip On Healthcare And Tariffs German Medtechs Tell Incoming Coalition

 
• By 

The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.

THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

Government Pulls ‘For Sale’ Signs From US FDA’s White Oak Campus

 
• By 

The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.

AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
• By 

Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

More from Guidance