AI-Enabled Tech Faces Dual Hurdles in FDA Regulation, Patent Law

Opinion: Companies developing AI-enabled health-care technologies should treat regulatory and IP strategies as parallel, ...
JD Supra

FDA Issues Guidance on AI for Medical Devices

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...
BioWorld

FDA, IMDRF at loggerheads over scope of PCCP guidances

The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans ...
JD Supra

Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices

On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...
Yahoo

CDRH shares regulatory guidance priorities for the coming 12 months

The Food and Drug Administration's headquarters is in Silver Spring, Maryland. This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily ...
Business Insider

PathAI Expands AISight® Dx Primary Diagnosis Clearance to Support VENTANA DP 200 and DP 600 Slide Scanners Through Predetermined Change Control Plan (PCCP)

BOSTON, Aug. 26, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced the expansion of the AISight® Dx digital pathology ...