Tag: FDA clearance
Radiology AI that clears Europe first faces a 17.5-month FDA wait
CE-first radiology AI waits a median 17.5 months for FDA clearance, an npj analysis finds.
Hyperfine wins second FDA clearance for Optive AI software
Hyperfine wins its second FDA clearance for Optive AI software on the portable Swoop MRI system.
Cortechs wins FDA nod for automated PET brain analysis
Cortechs.ai's NeuroQuant PET automates amyloid scan quantification after winning FDA 510(k) clearance.
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.
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.
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.