Category: Clearances

Clearances

Restore Robotics Receives FDA Clearance for Additional Remanufactured da Vinci Xi Instruments

Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.

Clearances

FDA Clears GE HealthCare’s MIM LesionID Pro for Automated Tumor Burden Analysis

The AI-enabled software automates whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies to help clinicians assess treatment eligibility and monitor response.

Clearances

FDA Clears Mobile C-Arm System With AI-Enhanced Imaging

The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.

Clearances

Restore Robotics Receives FDA Clearance for Additional Remanufactured da Vinci Xi Instruments

Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.

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.