Tag: FDA clearance
Stryker’s Vision Pro surgery app completes first hip case
SportSuite Vision, the first FDA-authorized app for intraoperative use on Apple's headset, debuts at Duke Health.
ROPCA’s autonomous ultrasound robot clears FDA for US entry
Danish medtech's Arthur robot and Diana software won 510(k) clearance for joint imaging.
Tempus’s ECG-PH lands as third cleared heart AI tool
Tempus ECG-PH reads standard 12-lead tracings for signs of elevated pulmonary artery pressure.
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.