Clearances

FDA Clears Deep Learning Technology for High-Resolution CT Imaging

The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.

Clearances

GE HealthCare Receives FDA Clearance for Diagnostic Imaging Viewer

The zero-footprint diagnostic viewer is designed to give radiologists browser-based access to imaging studies and visualization tools within the Genesis Radiology Workspace.

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 Clears Deep Learning Technology for High-Resolution CT Imaging

The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.

FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound

Aug 11, 2025

The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.

AI-Driven Coronary Physiology Software Gains FDA Clearance

Apr 18, 2025

The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.

FDA Clears Nanox.ARC X Imaging System

Apr 17, 2025

The system is cleared to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal indications.

FDA Clears AI Tool to Help Detect Lung Nodules and Triage Chest X-Rays

Apr 2, 2025

New FDA clearances authorize the use of an AI tool to detect lung nodules and help triage pneumothorax and pleural effusion on chest X-rays.

FDA OKs Inogen Simeox 200 Airway Clearance Device

Jan 2, 2025

The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.