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FDA Clears Robotic-assisted Surgery System for Urologic Procedures

The system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy.

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FDA Clears Sentec’s LuMon System for Bedside Lung Imaging

The LuMon system provides real-time, radiation-free lung imaging for premature infants, children, and adults, helping clinicians tailor respiratory therapy at the bedside.

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GE HealthCare Leads FDA AI Device Clearances for Fourth Consecutive Year

The company has now accumulated over 100 authorizations for artificial intelligence in its medical technology portfolio.

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FDA Clears Robotic-assisted Surgery System for Urologic Procedures

The system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy.

FDA Clears AI Tool for Detecting Low Ejection Fraction from ECGs

Jul 17, 2025

The software analyzes 12-lead ECGs to detect signs of low left ventricular ejection fraction in patients at risk of heart failure.

FDA Clears Handheld Robotic System for Ultrasound-Guided Needle Placement

Jul 10, 2025

Designed to assist with needle-based interventions, the system aims to reduce user variability and enhance procedural efficiency.

FDA Clears Home Airway Clearance System That Syncs Breathing with Chest Compressions

Jul 10, 2025

The FDA has cleared a new home airway clearance system that synchronizes breathing with chest compressions to support patients with chronic lung diseases such as COPD, cystic fibrosis, and bronchiectasis.