[Bellefonte, PA] – 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. It fits 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. This connection leaves the working channel available for other tools. The GripTract Fingers act like a “third hand” at the end of the endoscope. They enable 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. It is designed to enhance performance and precision during complex colonoscopy procedures. We are proud to continue advancing the forefront of medical technology. We 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. The funding came 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 healthcare technology innovator focused on motion-based solutions for gastroenterology and neurology. The team is driven by innovation, safety, and high-quality design. They aim to empower clinicians with precise, efficient tools that improve care and reduce costs.
The company follows a strategic path to commercialization. This includes multiple exit opportunities and feedback from leading industry experts. 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.
Actuated Medical has received two SBA Tibbetts Awards for SBIR commercialization excellence (2014 & 2020). The company operates from a 20,000 sq. ft. facility in central Pennsylvania. It is ISO 13485 certified and recognized as a Woman-Owned Small Business (WOSB). These achievements reflect a strong commitment to quality and innovation.
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.
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