Regulatory Approvals

FDA clears Imperative Care’s Symphony 16F 82cm catheter

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’s software solution gains CE mark for MRI imaging

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 gets FDA nod for AI-enhancement for surgical robot

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...

FDA clears robotic knee surgery system from Monogram Technologies

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...

FDA approves early feasibility study of Valcare’s transcatheter device

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...

FDA clears Caristo’s AI-powered CAD diagnostic software

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...

FDA approves GT Metabolic Solutions’ 50mm magnet in MagDI System

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

FDA clears Miach Orthopaedics ACL implant for expanded use

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 wins regulatory nod for laparoscopic surgical robot in China

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...
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