Browsing: FDA

Association of Medical Device Reprocessors issues statement following unanimous verdict in antitrust case against Johnson & Johnson’s Biosense Webster unit

Updates on AI projects from FDA, CMS, and NIH, a new National Coordinator for Health IT, and FDA clearance for a breast cancer prediction device

Medical technology company Signum Surgical announces positive first-in-human clinical data for BioHealx® Anal Fistula Device, supporting recent FDA De Novo clearance.

Medical device manufacturer Boston Scientific allegedly bypassed safety regulations for a spinal cord stimulator, with the FDA approving changes despite potential safety concerns.

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 Scott Schell of Cognizant discusses the implications of the FDA’s draft guidance on AI-enabled medical devices, highlighting the agency’s increasing regulatory focus on this technology.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