Actuated Medical Celebrates FDA 510(k) Clearance for their GripTract-GI™ Endoscopic Tissue Manipulator, Enhancing Complex Colonoscopy Visualization
BELLEFONTE, Pa. - Nov. 15, 2023 - PRLog -- Actuated Medical, a leading innovator in medical device technologies, proudly announces the receipt of FDA 510(k) clearance for its groundbreaking GripTract-GI™
GripTract-GI, developed and patented by Actuated Medical's team of experts, is designed to revolutionize endoscopic tissue manipulation, offering unparalleled maneuverability and versatility. With this FDA clearance, Actuated Medical reaffirms its commitment to delivering cutting-edge solutions that elevate patient care and procedural outcomes.
"The FDA clearance for GripTract-GI is a testament to Actuated Medical's dedication to innovation and excellence in medical device development,"
GripTract is a single-use device that connects to the distal end of an endoscope without occupying the working channel. It assists clinicians with optical visualization, diagnosis, and endoscopic treatment. It was developed under National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding.
Actuated Medical's relentless pursuit of excellence is reflected not only in the GripTract-GI but also in the company's overall portfolio, which spans various medical specialties. The FDA clearance reinforces Actuated Medical's position as a leader in medical device innovation, poised to make a lasting impact on the landscape of minimally invasive procedures.
About Actuated Medical:
Actuated Medical is a medical device product innovator with an impressive portfolio boasting six FDA 510(k) clearances, over 41 US and International patents, and three products already making waves in early sales. Their unwavering focus on neuroscience, gastrointestinal, critical care, and pediatrics is reshaping the landscape of medical technology. Operating from a cutting-edge 20,000 sq.ft. facility in central Pennsylvania, their ISO 13485 and WOSB certifications underscore their commitment to quality. Honored with two SBA Tibbets Awards for SBIR commercialization excellence and the 2020 Life Sciences PA CEO of the Year award, Actuated's remarkable journey includes a pivotal role in addressing the PPE shortage during the COVID crisis.
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