Tag: FDA clearance
a2z Radiology clears FDA for 10 more findings on abdominal CT
One clearance lifts the Boston company's abdominal triage portfolio to 17 findings across two devices.
Medtronic wins FDA nod to bring LigaSure onto the Hugo robot
The clearance puts Medtronic's vessel-sealing technology, used in 45 million procedures, onto its own robotic surgery platform.
Omniscient clears FDA to map DBS leads with connectomics
Quicktome Deep Brain becomes the Sydney company's third FDA clearance, extending its brain-network platform into deep brain stimulation.
Queen of Hearts ECG AI wins FDA nod for heart attacks
The FDA cleared Powerful Medical's Queen of Hearts model to flag STEMI and occlusive heart attacks on ECGs, including patterns…
Heartvue’s cardiac MRI AI clears FDA with self-update built in
FDA clearance for Heartvue.Proton includes a PCCP that lets the cardiac MRI AI learn without refiling.
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.