The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are.

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to ...

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate ...

A digital companion, purpose-built for surgical patients’ pre- and post-operative journeys, is now an imperative for providers, payers, and medtech leaders aiming to achieve competitive ...

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new ...

WALTHAM, Mass.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced a definitive agreement to acquire Clario Holdings, Inc., a leading ...

Rejected by leading customers Physicians as customers/intermediary complicates adoption pathways. Emerges in niche/small markets Sophisticated epidemiology and real-world data allow larger initial ...

Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial ...

A new EU Commission study on the Deployment of AI in Healthcare makes one thing crystal clear: AI isn’t just a buzzword, it could be the lifeline our systems desperately need. I’m a startup advisor ...

Having enjoyed tremendous success and growth in value-based care models, I am passionate about helping other primary care practices thrive in the shifting healthcare climate. I help healthcare ...

The rise of AI-powered health apps that claim to diagnose conditions in real time is transforming how we approach healthcare. From symptom checkers to wearable ECG monitors and AI stethoscope apps, ...

Inspira Technologies has received U.S. Patent approval for its ART500 device. The patent is for low flow rates extracorporeal oxygenation system and methods of use and represents the core technology ...