Regulatory Approvals

The company had previously received FDA clearance to use its prescription wearable to treat migraines at onset. Prescription digital therapeutic developer Theranica announced it has received FDA...

Elekta (Stockholm:EKTA-B) says an FDA 510(k) clearance represents a new era in precision radiation therapy to treat cancer in the U.S. The Sweden-based cancer and...

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...