FDA Grants 510(k) Clearance for Novel Endoscopic Ultrasound Device

The Food and Drug Administration (FDA) has cleared the EndoSound Vision System (EndoSound), a modality that may help broaden access to endoscopic ultrasound for gastrointestinal diseases.

EndoSound said the EndoSound Vision System (EVS) can be attached to existing upper gastrointestinal endoscopes. While the company noted that 95 percent of endoscopic ultrasound services are performed in hospital settings, it maintained that the “more economical” EVS may allow more use of the technology in ambulatory care settings.

The EndoSound Vision System, which previously garnered an FDA Breakthrough Device Designation in July 2021, provides detailed gastrointestinal imaging, and also addresses the issue of infections that may occur with endoscope elevators that are difficult to clean, according to EndoSound.

“This (FDA clearance) milestone underscores our commitment to advancing medical technology and improving patient outcomes. With the EVS, we aim to not only enhance the safety of endoscopic procedures but also contribute to expanding access to care for patients worldwide,” noted Stephen Steinberg, M.D., the president and CEO of EndoSound.

(Editor’s note: For related content, see “Endoscopic Ultrasound Biopsy Modality Gets FDA Nod” and “AI-Powered Liver Tumor Ablation Software Leverages CT, MRI and Ultrasound for Real-Time Image Guidance” and “Diagnostic Imaging’s Top Five Ultrasound Content of 2023.”)