G-Tech Medical Receives FDA Clearance for its
MOUNTAIN VIEW, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) — G-Tech Medical, a developer of non-invasive diagnostic solutions for patients with gastrointestinal disorders, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Wireless Patch System (WPS) for non-invasive myoelectric activity measurement.
The G-Tech WPS is a tool that provides gastric and intestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical researcher to aid in the diagnosis and evaluation of gastrointestinal disorders.
“We are excited to receive our first regulatory clearance,” said Steve Axelrod, CEO of G-Tech. “This is a key achievement in support of our ultimate goal of providing a motility solution that localizes the sources and identifies the nature of GI disorders.”
Gastrointestinal (GI) motility is the underlying factor in a wide range of disorders and dysfunction experienced by tens of millions in the U.S. GI disorders include inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and other functional gastrointestinal disorders (FGID’s).1 GI dysfunctions are also prevalent during recovery from abdominal surgery which can lead to post-operative ileus (POI).2
Current motility technologies are typically limited in scope, invasive and only sample for a brief time period in a non-physiological setting, such as a hospital or physician office. The G-Tech product, in contrast, measures myoelectrical signals from the stomach, small intestines and colon over multiple days non-invasively in a variety of settings.
G-Tech will continue to prioritize investment in clinical trials in the near term.
“It’s all about the data. Developing a large, proprietary data set which we can mine and analyze to drive new learnings, and correlate motility with specific GI issues, is key for us,” said Axelrod. “We truly believe our ‘EKG for the Gut’ will become a standard of care in gastroenterology over time. Growing our patient motility database is the shortest path to that future.”
- Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10. Erratum in: Gastroenterology. 2019 May;156(6):1936. PMID: 30315778; PMCID: PMC6689327.
- Nachlas, MARVIN M., M. Tewfic Younis, C. Pio Roda, and JOSEPH J. Wityk. “Gastrointestinal motility studies as a guide to postoperative management.” Annals of surgery 175, no. 4 (1972): 510.
About G-Tech Medical
G-Tech Medical, Inc. is an early-stage medical device company dedicated to developing low-cost, non-invasive gastrointestinal monitoring solutions for patients with chronic GI disorders. G-Tech’s wearable wireless patch will provide patient-specific motility data to physicians, helping them assess underlying causes of GI disorders and develop targeted therapies. The company is headquartered at Fogarty Innovation, 2495 Hospital Drive, Suite 300, Mountain View, CA 94040. For further information, please visit www.GTechMedical.com or email email@example.com.