The FDA cleared the CT-to-fluoroscopy (CT-Fluoro) registration method for Augmedics' Xvision Spine System. The device uses augmented reality to give surgeons “X-ray vision” during...
BrightHeart received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of the fetal heart. The Paris-based company designed its AI...
Dutch company Xeltis shared that the US Food and Drug Administration (FDA) granted breakthrough device designation to its lead product, called aXess, which will...
Magstim announced that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS). Clearance paves the way for the use...
Momentis Surgical announced the FDA granted 510(k) clearance for its second-generation Anovo surgical robot. Last month, Anovo received clearance for use in single-site, abdominal...
SimBioSys received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons in the U.S.
Chicago-based SimBioSys picked up an...
Corin received FDA 510(k) clearance for its Icona femoral stem implant for total hip arthroplasty (THA). This clearance comes just one month after Corin...
