FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
Category: Clearances
Clearances
Latest
Clearances
Latest
Microbot Medical Submits Liberty Robotic System For FDA Review
Microbot Medical has submitted a 510(k) notification for Liberty, its single-use robotic system for endovascular procedures.
Clearances
Latest
FDA Clears CMR Surgical to Market Versius Surgical System
The FDA approved marketing for CMR Surgical's Versius Surgical System, designed to assist in minimally invasive soft tissue surgeries.
Clearances
Latest
FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
Diality Receives FDA Clearance for Moda-flx Hemodialysis System
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.
Read More
Varian Receives FDA Clearance for IntelliBlate Ablation System
Varian received FDA 510(k) clearance for its IntelliBlate microwave ablation system, designed for soft tissue ablation.
Read More
FDA Grants Restore Medical ContraBand Breakthrough Designation
Restore Medical’s ContraBand device received FDA Breakthrough Device Designation for treating heart failure with reduced ejection fraction.
Read More
Postrigo NeuroLF PET System Nabs FDA Clearance
Positrigo, a Swiss company, received FDA clearance for its NeuroLF brain PET system, designed to diagnose and monitor brain disorders.
Read More
FDA Clears ImmersiveTouch ImmersiveAR Platform
ImmersiveTouch has received FDA clearance for its ImmersiveAR platform, an augmented reality technology to enhance surgical planning.
Read More
FDA OKs AgileMD eCART Clinical Deterioration Suite
The FDA has granted 510(k) marketing clearance for AgileMD’s eCART Clinical Deterioration Suite for assessing patient condition.
Read More
Clearances
Latest
FDA Clears Clarius Mobile Health OB AI Fetal Biometric Tool
Clarius Mobile Health has received U.S. FDA clearance for its OB AI tool, which uses deep learning to provide accurate fetal measurements.
