Regulatory Approvals

Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed...

Accelus has announced that the U.S. Food & Drug Administration (FDA) had cleared its 510(k) application for its Remi™ Robotic Navigation System software update...

Caption Health, the leader in using AI and services to improve access to heart ultrasound diagnostics, announced new regulatory approvals to market its Caption...

Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The test is run...

ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. Procise CRP gives quantitative determination of CRP levels in patient serum...

The TriVerse primary knee system aims to provide cruciate retaining along with anterior and posterior stabilised constructs. Exactech has obtained 510(k) clearance for its TriVerse primary knee replacement...

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced it has received...

The CurvaFix IM Implant follows the natural curvature of a patient’s bone shape and fills the space in the pelvis. CurvaFix has obtained 510(k) clearance for its...

The Impella RP Flex is indicated to provide temporary right ventricular support for up to 14 days. The US Food and Drug Administration (FDA) has granted pre-market...