EndoSound is delighted to announce that its EndoSound Vision System® (EVS) has received FDA clearance, marking a significant advancement in endoscopic ultrasound (EUS) technology. The EVS, designed with a strong emphasis on safety features, seamlessly integrates into existing endoscopy centers, promising a transformative impact on the field of EUS procedures. Acknowledged as a Breakthrough Device by the FDA, the EVS addresses key aspects such as patient safety, cost reduction, and enhanced accessibility to critical medical care.
With a strategic focus on transitioning care to more efficient settings like ambulatory surgery centers (ASCs), the EVS aims to broaden the accessibility of EUS procedures. This regulatory clearance serves as a testament to the system's effectiveness and safety, affirming EndoSound's dedication to advancing healthcare through innovative technologies.
Endoscopic Ultrasound (EUS) is a minimally invasive procedure used for assessing diseases of the gastrointestinal tract and adjacent organs and tissues. By producing detailed images of the pancreas, liver, and gallbladder using high-frequency sound waves, EUS plays a crucial role in diagnostic procedures. Presently, over 95% of EUS patients are treated in hospital settings, but the EVS aims to redirect a majority of these cases to more efficient and patient-preferred settings like ASCs.
Source: https://www.endosound.com/evs-receives-510k-clearance/
