Medical technology company EndoSound has achieved a significant milestone with the recent receipt of FDA 510(k) clearance for its groundbreaking EndoSound Vision System (EVS). This development positions the company at the forefront of medical innovation, particularly in the field of endoscopic ultrasound (EUS), as it introduces a system designed to attach to upper gastrointestinal endoscopes.
Headquartered in Portland, Oregon, EndoSound has meticulously crafted the EVS to seamlessly integrate into any endoscopy center’s existing ecosystem, offering access to both imaging and therapeutic procedures. The company envisions that the EVS could play a transformative role in shifting the site of care to more efficient settings like ambulatory surgery centers (ASCs). The company boldly labeled the EVS as “poised to revolutionize the landscape of EUS,” emphasizing its potential impact on the medical field.
The EVS, initially designated as a FDA breakthrough device in 2021, addresses infections associated with challenging-to-clean endoscope elevators. The minimally invasive procedures performed with this system enable the assessment of diseases affecting the gastrointestinal tract and extend to nearby organs and tissues. By utilizing high-frequency sound waves, the EVS produces detailed images of crucial structures such as the pancreas, liver, and gallbladder.
Dr. Stephen Steinberg, President and CEO of EndoSound, expressed enthusiasm about achieving FDA clearance for the EVS, attributing the success to the dedication and innovation of the entire EndoSound team. Dr. Steinberg emphasized the company’s commitment to advancing medical technology and improving patient outcomes, stating, “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.”
Further, the EVS’s capabilities extend beyond imaging, addressing the challenges associated with difficult-to-clean endoscope elevators and providing a safer and more efficient platform for endoscopic procedures. This clearance marks a crucial step forward for the company in fulfilling its mission to bring cutting-edge medical technology to the forefront of patient care.
EndoSound’s innovative EVS not only showcases the company’s commitment to advancing medical technology but also underscores its dedication to improving patient safety and expanding global access to care. As the EVS prepares to make a significant impact on the landscape of endoscopic ultrasound, the company positions itself as a key player in the evolution of medical technology.
The FDA clearance of EndoSound’s EVS signifies a noteworthy achievement in the realm of endoscopic ultrasound technology, promising enhanced safety and expanded access to care for patients around the world.