Regulatory Approvals

EBR Systems announced that it received FDA approval for its wireless cardiac pacing device for heart failure. The FDA approved its WiSE cardiac resynchronization...

CeriBell received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm. Clarity detects electrographic seizures in patients ages one and older. The company says...

DESKi announced FDA clearance of HeartFocus, its AI-enabled heart exam software. Bordeaux, France–based DESKi says it only takes a few hours of training for any...

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...