Auckland-based health technology startup Alimetry has received clearance from the U.S. Food and Drug Administration for wearable devices for diagnosing gastric disorders.
Gastric orthotics is a non-invasive test for nausea and vomiting, gastroparesis, and general abdominal disorders, including functional dyspepsia.
In addition to the FDA clearance, the company also owns Alimetry, Inc., a subsidiary of Minneapolis, Minnesota. Has announced the launch, which will market and distribute diagnostic tests in the United States.
What is it about
According to a media release, gastric alimentary examination is performed only in a clinical setting. Recordings are taken before and after meals when patients simultaneously log their symptoms into a companion mobile app. The wearable device captures digestion patterns from the surface of the skin and then provides clinical reports through the cloud, which ultimately informs the diagnosis of gastric disease and supports personalized therapy.
The test, which is currently marketed in the United Kingdom and New Zealand, will be commercially available in the United States from July.
Why it matters
Greg O’Grady, CEO and co-founder of Alimetry, claims that existing bowel tests are performed on “often unreliable and disposable” patients over months or years, often costly, invasive and involving radiation.
For the company, Gastric Elymetry is a “game-changing” tool that will bring more precision to the gastric diagnostic field and enable improved clinical results and “safer, more accessible, and less invasive care.”
Snapshots of the market
Wearable patches are manufactured and marketed in the United States to track and detect gastrointestinal problems. In 2018, researchers The University of California San Diego has developed a wearable device that can track electrical activity in the abdomen within a 24-hour period. G-Tech Medical, also from California, has developed a wearable, disposable sensor patch for measuring electrical activity in the gastrointestinal tract.
Recently, digital therapies for the treatment of stomach problems have come on the market, including Metami Health Reguls and Cara Care.