Regulatory Approvals

Bruno Vision Care, a leader in eye care innovation, received FDA approval to sell its Deseyne® (vifilcon C) daily disposable contact lens with FusionTechnology...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Turbett Surgical’s improved line of Instrument Pods, notably the TS1500, TS1200, and...

Intuitive received FDA clearance for its fully wristed SP SureForm 45 stapler. The stapler works with the surgical robotics leader’s da Vinci SP surgical system in...

Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds...

HighLife, a company focused on development of a novel trans-septal mitral valve replacement (TSMVR) system for moderate to severe mitral regurgitation (MR), has received...

CardioVia announced today that it received FDA clearance for its minimally invasive ViaOne epicardial access system. The company designed its device to enable safe, precise...

ICU Medical, a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food...

Inspira has completed the first real-world procedure of its extracorporeal blood circulation device at New York’s Westchester Medical Center. The Israeli company’s Inspira Art100 system...

Paige, a leader in next-generation AI technology, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect,...