Clearances

FDA Clears for Augmented Reality Navigation Platform for Neurosurgery

The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.

Clearances

Movano’s EvieMED Ring Cleared by FDA for Pulse Oximeter

Movano Health’s EvieMED Ring received FDA 510(k) clearance for its pulse oximeter, enabling expansion into clinical markets.

Clearances

Paragonix Gets FDA Clearance for KidneyVault Perfusion Device

Paragonix Technologies received FDA 510(k) clearance for KidneyVault, a portable kidney preservation device with digital monitoring.

Clearances

FDA Clears for Augmented Reality Navigation Platform for Neurosurgery

The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.

FDA OKs Siemens Healthineers Acuson Origin

Aug 13, 2024

Siemens Healthineers has received U.S. FDA clearance for the AI-powered Acuson Origin cardiovascular ultrasound system and the AcuNav Lumos 4D ICE catheter, both designed to improve cardiac diagnostics and patient care.

Masimo W1 Watch Receives FDA Clearance for Connectivity

Aug 12, 2024

The Masimo W1 medical watch received FDA clearance for connectivity, enabling integration with the Masimo SafetyNet telemonitoring solution.

Diality Receives FDA Clearance for Moda-flx Hemodialysis System

Aug 7, 2024

Diality has received U.S. FDA 510(k) clearance for its Moda-flx Hemodialysis System, designed to support various dialysis treatments and improve usability across multiple care settings.