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FDA maps a doctor-like testing path for generative AI devices
The FDA's new discussion paper proposes doctor-style competency testing for generative AI medical devices before they reach patients.
FDA roster of cleared AI medical devices passes 1,500
FDA marketing authorizations for AI-powered medical tools have passed 1,500, with oncology among the fastest-growing categories.
Sleep ring maker Happy Health banks $75M for home care push
Happy Health raised $75M to build AI-powered home care around a smart ring that screens for sleep apnea.
GenBio launches stateful AIDO Cell to simulate whole human cells
GenBio AI launches AIDO Cell, a stateful virtual cell that predicts how DNA, RNA and proteins shape whole-cell behavior.
J&J’s Monarch bronchoscopy robot adds AI planning in Quest 3
FDA clearance brings AI nodule planning and sharper navigation to J&J's Monarch lung biopsy robot.
Craif’s $33M Series D funds AI urine test for pancreatic cancer
Japanese bio-AI startup Craif banks $33M to push its urine-based pancreatic cancer test toward US launch.
Eye-tracking AI spots lazy eye from fixation patterns alone
An AI classifier trained on eye-movement data may spot amblyopia in patients who cannot complete standard vision tests.
PRISM reads plain MRI to spot liver tumors without contrast dye
Deep learning framework PRISM diagnoses liver lesions on contrast-free MRI, cutting radiologist reading time by up to two-thirds.