Clearances

FDA Clears 3T Neonatal MRI System Designed for Use in the NICU

The system features a compact footprint and is designed for whole-body imaging in neonatal care settings.

Clearances

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.

Clearances

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

FDA Clears 3T Neonatal MRI System Designed for Use in the NICU

The system features a compact footprint and is designed for whole-body imaging in neonatal care settings.

FDA Clears CMR Surgical to Market Versius Surgical System

Oct 16, 2024

The FDA approved marketing for CMR Surgical’s Versius Surgical System, designed to assist in minimally invasive soft tissue surgeries.

Natus Medical Submits FDA 510(k) for Point-of-Care EEG Device

Oct 11, 2024

Natus Medical submitted an FDA 510(k) notification for its point-of-care EEG device, designed to identify seizures in acute care settings.

FDA OKs SamanTree Medical Histolog Scanner

Sep 13, 2024

SamanTree Medical’s Histolog Scanner has received FDA 510(k) clearance for imaging the internal microstructure of tissues, such as cells and vessels.

FDA OKs AISAP Cardio Ultrasound Platform

Aug 23, 2024

AISAP has received U.S. FDA 510(k) clearance for its AI-powered AISAP Cardio platform, which provides comprehensive point-of-care cardiac ultrasound diagnostics and integrates into clinical workflows.

FDA Clears Procept BioRobotics Hydros Robotic System

Aug 21, 2024

Procept BioRobotics has received FDA clearance for its AI-powered Hydros Robotic System, which integrates advanced imaging to improve urology procedures and will be available in U.S. hospitals soon.

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.