Tag: FDA clearance
Freenome’s AI blood test for lung cancer gains FDA fast track
The FDA fast-tracked Freenome's AI blood test for lung cancer, weeks after clearing its colorectal screen.
Ceribell’s AI EEG readers clear FDA review
The FDA cleared two Ceribell AI algorithms that detect epileptiform patterns and clean up EEG recordings on its Neurology Portal.
World-first AI kidney stone surgery robot clears FDA review
Korea's Roen Surgical won FDA 510(k) clearance for Zamenix, an AI-guided flexible ureteroscope robot for kidney stone surgery.
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.