EDAP nets FDA approval for ultrasound device

Justine Varieur Cadet | | Health Exec | EMR/EHR
The FDA has granted 510(k) marketing clearance to therapeutic ultrasound developer EDAP TMS for its Sonolith I-Sys device.

Sonolith I-Sys is a robotized, integrated lithotripter used to disintegrate urinary stones in association with combined x-ray or ultrasound systems, according to the Lyon, France-based company.

The Sonolith I-Sys received CE mark approval in July 2007 and was launched in the European Union in late 2007.

Justine Varieur Cadet

Related Content

Private equity-backed cardiology group puts cloud-based technology in hands of its cardiologists
AI helps cardiologists deliver personalized healthcare—but there is still plenty of work to do
Indiana hospitals reduce nuisance alerts by 77% with medication decision support software
Leveraging machine learning to rapidly create clinical AI algorithms
How medication reconciliation data consolidation in the EHR enables better patient care
How are the best in KLAS Health IT vendor rankings created?

Around the web

Cardiovascular Business
Payment cuts and beyond: Key takeaways for cardiologists from the 2025 Medicare Physician Fee Schedule

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

AI in Healthcare
A modest proposal to rally AI regulators around a simple game plan

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

Cardiovascular Business
FDA commissioner urges clinicians to join fight against medical misinformation

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Design by Adaptive Theme
Trimed Popup
Trimed Popup