Alimetry gets FDA clearance for wearable gut disorder test

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Auckland-based health technology startup Alimetry has received clearance from the US Food and Drug Administration for its wearable device for diagnosing gastric disorders.

Gastric Alimetry is a non-invasive test for common stomach disorders, including nausea and vomiting, gastroparesis, and functional dyspepsia.

Alongside the FDA clearance, the company announced the launch of Alimetry, Inc., its subsidiary based in Minneapolis, Minnesota, which will market and distribute the diagnostic test in the US.

WHAT IT’S ABOUT

According to a media release, the Gastric Alimetry test is only performed in a clinical setting. Recordings are taken before and after a meal while patients simultaneously log their symptoms into a companion mobile app. The wearable device captures digestive patterns from the skin surface and then delivers clinical reports via the cloud, which ultimately informs the diagnosis of gastric diseases and supports personalised therapy.

The test, which is currently marketed in the United Kingdom and New Zealand, will be commercially available in the US from July.

WHY IT MATTERS

Greg O’Grady, CEO and co-founder of Alimetry, claims that existing gut tests are “frequently unreliable and inconclusive” with patients undergoing months or years of testing, which is often costly, invasive, and involves radiation. 

For the company, Gastric Alimetry is a “game-changing” tool that will bring more clarity to the gastric diagnostic field and enable enhanced clinical outcomes and “safer, more accessible, and less-invasive care”.

MARKET SNAPSHOT

Wearable patches have been developed and marketed in the United States to track and identify gastrointestinal issues. In 2018, researchers from the University of California San Diego created a wearable device that can track electrical activity in the stomach over 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 therapeutics treating abdominal problems have sprung up in the market, including metaMe Health’s Regulora and Cara Care.



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