Tag: Medical Devices
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.
Philips pockets $33.7M to automate stroke intervention care
Philips wins an up-to-$33.7M ARPA-H award to automate robotic stroke interventions and close the thrombectomy access gap.
Medtech veteran tipped to lead AI oversight at FDA
HHS is standing up two new FDA deputy commissioner posts, with a medtech veteran tipped to oversee AI.
Globus Medical buys Higgs Boson Health for surgical intelligence
Globus Medical adds a Duke-born software team to build AI-driven surgical intelligence across the care journey.
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.
Study finds almost no FDA-cleared AI devices tested on outcomes
A PLOS Digital Health study finds only three of 1,357 FDA-cleared AI devices were ever tested on patient outcomes.
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.