Tag: FDA clearance
Leica Biosystems scores FDA nod for first AI pathology QC software
The Danaher unit won FDA clearances including the industry's first standalone AI-assisted quality control software for digital pathology.
GE HealthCare rolls out AI breast ultrasound pair for dense tissue screening
GE HealthCare launches an AI-powered automated breast ultrasound system and a browser-based remote viewer for dense breast screening.
Samsung’s Galaxy Ring wins first FDA nod for over-the-counter sleep apnea screening
Samsung's Galaxy Ring becomes the first over-the-counter smart ring cleared by the FDA to flag sleep apnea risk.
UpDoc gets first FDA clearance for patient-facing LLM in diabetes care
The clearance raises questions about whether generative AI serves as an interface or a clinical decision-maker.