Ultrasound developer EndoSound announced it has received FDA 510(k) clearance for its EndoSound Vision System (EVS), an endoscopic ultrasound device that the company calls a “first-of-kind” technology.
The EVS, which integrates into existing endoscopy centers, offers a more cost-effective solution for endoscopic ultrasounds, aiming to broaden access to the critical imaging and therapeutic procedure. EndoSound said it anticipates its EVS will shift the site of endoscopic ultrasounds to outpatient care settings, such as ambulatory surgery centers and urgent care clinics preferred by patients, providers and payers.
This announcement follows the company's FDA Breakthrough Device designation in 2021, which emphasized the safety features of the EVS and its potential to improve patient access.
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