While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in ...

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking ...

The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS ...

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the ...

The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are. The pilot supports innovative tools and a health care delivery model that ...

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 ...

Examines the increasing strain on caregivers in home-based care models, the level of support they need for various stages of care, and how improved technological devices and infrastructure can help ...

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 ...

Bryan Gilpin is President of Suntra MedTech Solution. He’s a hands-on, engineering-oriented executive with experience developing, manufacturing, selling, distributing and supporting bio-medical ...