FDA grants 510(k) clearance to EndoSound’s add-on endoscopic ultrasound device
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The FDA has granted 510(k) clearance to EndoSound for its Vision System, a novel endoscopic ultrasound device that attaches to upper gastrointestinal endoscopes, according to a company release.
Previously granted FDA breakthrough designation in July 2021, the EndoSound Vision System (EVS) is a supplemental device, consisting of an ultrasound beamformer, reusable transducer and disposable mounting kit, which fastens onto a flexible upper GI video endoscope to modify it into an endoscopic ultrasound system.
“We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team,” Stephen Steinberg, MD, president and CEO at EndoSound, said in the release. “This 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.”
The device may be economically integrated into any endoscopy center and provides greater access to imaging and therapeutic procedures compared with conventional endoscopic ultrasound devices, the release stated.
The company noted that “EVS is poised to revolutionize the landscape of EUS,” expanding the availability of this critical modality to ambulatory surgery centers that are preferred by patients, providers and payers.
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