Regulatory Approvals

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...

Moon Surgical announced it received FDA clearance for ScoPilot, a Nvidia-enabled platform for its Maestro surgical robot. The Paris-based company also announced further integrations...

Monogram Technologies received FDA 510(k) clearance for its mBôs total knee arthroplasty (TKA) system. The company designed mBôs to deliver safety, efficiency and accuracy...

The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility...

The US Food and Drug Administration (FDA) has granted clearance to Caristo Diagnostics for CaRi-Plaque, an AI-assisted software application that diagnoses coronary artery disease...

GT Metabolic Solutions’ use of a 50mm magnet in the MagDI System has received clearance from the US Food and Drug Administration (FDA), supporting...