Companies that recognize AI governance as a strategic capability rather than a compliance burden will capture disproportionate value.

Belfast, Northern Ireland — Today, weʼre proud to share a major milestone: the FDA has granted clearance for a Predetermined Change Control Plan (PCCP) for our patented, AI-driven segmentation ...

The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans for software as a medical device. The problem for advocates of regulatory ...

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 ...

Artificial-intelligence (AI)-enabled medical devices are proliferating globally, with the U.S. FDA tallying almost 1,000 cleared products as of mid-2024.¹ Latin America (LATAM) is simultaneously ...

The FDA continuously updates its list of devices that utilize AI and machine learning (ML) technologies, which has shown exponential growth since 2018. Algorithms for stroke, breast cancer, and lung ...

PARIS and SAN FRANCISCO, July 2, 2025 /PRNewswire/ -- Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: ...