Regulatory Approvals

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...

The US Food and Drug Administration (FDA) has cleared Miach Orthopaedics Bridge-Enhanced ACL Restoration (BEAR) implant for expanded use in treating complete and partial...

Ronovo Surgical has received regulatory approval for its Carina surgical robotic platform in China. Shanghai-based Ronovo develops broad, cross-specialty robotic-assisted surgery (RAS) technology. It...

Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for the Intercept Blood System for platelets and...