Browsing: FDA

Alibaba’s Damo Academy research arm receives FDA ‘breakthrough device’ designation for AI-powered cancer detection tool, Damo Panda

Dr. Scott Schell of Cognizant discusses the implications of the FDA’s draft guidance on AI-enabled medical devices, highlighting the agency’s increasing regulatory focus on this technology.

AdvaMed outlines key principles to promote broader access to digital health technologies, including AI/ML, and FDA-regulated innovations.

Expert advice on designing transparent and effective clinical trials for medtech startups.

The rapid evolution of artificial intelligence in healthcare demands proactive policies to maximize its potential. This article discusses the AI Policy Packet, a resource outlining key recommendations for Congress to ensure continued innovation in AI-enabled medical technology.

Powerful Medical’s PMcardio STEMI AI ECG model gains Breakthrough Device Designation from the FDA, aiming to revolutionize heart attack detection and improve patient outcomes.

Hims’ Super Bowl ad has drawn criticism for its provocative claims about the weight loss industry and pharmaceutical companies.

A new study reveals manufacturers often submit medical device adverse event reports late. Also, senators are questioning telehealth platforms’ ties to pharmaceutical companies, and Hinge Health plans its IPO.

A recap of significant developments in health technology, including late FDA reports on adverse events, senators questioning telehealth-pharma ties, a look at Hinge Health’s IPO plans, and Apple’s Parkinson’s tech.

Johnson & Johnson MedTech announced new regulatory clearances for its orthopedic technologies, including the VOLT system and Inhance Intact system.