EDAP nets FDA approval for ultrasound device
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.
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.