Actuated Medical Secures FDA 510(k) Clearance for GripTract-GI™ Endoscopic Tissue Manipulator, a Major Advancement in GI Procedural Innovation

BELLEFONTE, Pa. - Dec. 3, 2024 - PRLog -- Actuated Medical, a leading innovator in medical device technologies, proudly announces the receipt of a second FDA 510(k) clearance for its GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) product line. GripTract is now indicated as an accessory for lower GI endoscopes with diameters from 11.5 to 13.3 millimeters and working lengths of 130 to 170 centimeters. Designed as a single-use device, GripTract connects to the distal end of an endoscope leaving the working channel available for other tools. The GripTract Fingers are like a 'third hand' at the end of the endoscope enabling clinicians to enhance optical visualization, diagnosis, and endoscopic treatments.

"GripTract's expanded indication represents a significant milestone in Actuated Medical's ongoing mission to advance the treatment of GI cancers. This expansion empowers physicians with a highly effective solution designed to enhance performance and precision during complex colonoscopy procedures. We are proud to continue advancing the forefront of medical technology and are deeply committed to providing groundbreaking tools that improve patient outcomes and elevate the standard of care."

— Maureen L. Mulvihill, Ph.D., Actuated Medical President & CEO

GripTract was developed with Small Business Innovation Research (SBIR) funding from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIDDK-NIH).

About Actuated Medical, Inc.

Actuated Medical is a medical technology innovator that is pioneering motion-based solutions to address critical, unmet clinical needs in gastroenterology and neurology. With an unwavering focus on innovation, safety, and superior quality, the Actuated team is committed to delivering transformative products that empower healthcare professionals to achieve greater precision, enhance efficiency, and drive better patient outcomes while reducing healthcare costs. The company's technologies are backed by a strategic path to commercialization with multiple exit opportunities, supported by invaluable feedback from industry leaders. Actuated holds 42 issued U.S. and international patents, 8 FDA 510(k) clearances, 5 Investigational Device Exemptions (IDEs), 33 pre-submissions, and has completed or is conducting 8 clinical studies. Honored with two Small Business Administration (SBA) Tibbetts Awards for SBIR commercialization excellence (2014 & 2020), Actuated operates out of a state-of-the-art 20,000 sq. ft. facility in central Pennsylvania, certified with ISO 13485 and as a Woman-Owned Small Business (WOSB), reflecting its steadfast commitment to quality and innovation. actuatedmedical.com

NIH Disclaimer.

Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIDDK-NIH) under Award Number DK117813. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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For media inquiries, please contact Maureen L. Mulvihill, Ph.D. by phone at 814-355-0003 or email at info@actuatedmedical.com.

Additional information can be found by visiting:

ActuatedMedical.com

GripTract.com

ActuatedNeuroscience.com

TubeClear.com

Mitotyping.com