Regulatory Approvals

RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced it has received FDA 510(k) clearance for Rapid...

Medasense Biometrics Ltd. announced that  the U.S. Food and Drug Administration (FDA) has granted marketing authorization to the PMD-200 patient monitor with NOL® technology developed...

Origami Surgical announced that it received FDA clearance for the insertion and removal of its StitchKit device. Madison, New Jersey-based Origami’s new FDA indication allows for...

Medtronic plc (NYSE:MDT) has received CE (Conformité Européenne) Mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation...

Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable...

Alabama-based technology company Curiteva announces the first FDA 510(k) cleared 3D-printed PEEK implant, the Inspire Porous PEEK Cervical Interbody System with HAFUSE Technology. The Inspire platform is...

Belgium-based scale-up, Sunrise, announced the U.S. Food and Drug Administration (FDA) has cleared for use its second generation at-home sleep apnea test that uses artificial...

The IDE approval will enable data on the safety and efficacy of the Magic Touch PTA Sirolimus Coated Balloon to be collected. The US Food...

AI-powered image analysis tool expedites oral health analysis and measures radiographic signs of periodontal disease VideaHealth, the trusted dental artificial intelligence (AI) platform, announced the...