Regulatory Approvals

The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants...

Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA). This designation is significant not...

MedCAD has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AccuStride Foot and Ankle System. This clearance permits the company...

Enable Injections’ enFuse Syringe Transfer System has secured CE mark approval under the European Union Medical Device Regulation (EU MDR). This approval allows the company...

SiBionics unveiled its GS3 continuous glucose monitor (CGM), which now has CE mark approval. The company unveiled the device — which it touts as...

The US Food and Drug Administration (FDA) has cleared Vent Creativity’s Hermes Knee, an AI-driven software solution for knee arthroplasty procedures. The solution uses deep...

Newronika announced it received CE mark approval for its AlphaDBS device for treating Parkinson’s disease. AlphaDBS, the company’s next-generation, closed-loop deep brain stimulation (DBS) system...

Imperative Care announced FDA 510(k) clearance of its Symphony 16F 82cm catheter for venous thrombosis and announced the first successful cases. Campbell, California-based Imperative...

Subtle Medical has gained the CE mark certification in Europe for its software solution SubtleHD, designed to enhance the quality of magnetic resonance imaging...