Medically reviewed by Onikepe Adegbola, MD, PhD
Alimetry, a medical device, and digital healthcare firm said today that it has gained US Food and Drug Administration (FDA) approval for Gastrointestinal Alimetry, an innovative non-invasive medical device that aids in the identification of gastric problems. Alimetry also announced today the formation of Alimetry Inc., a company headquartered in Minneapolis, Minnesota, that will market and sell Gastric Alimetry in the United States.
Professor of Surgery and co-founder of Alimetry, Greg O’Grady, said that Gastric Alimetry is a first-of-its-kind and true advancement in gut diagnostics. Alimetry’s proprietary technology combines the power of stretchable electronics, wearables, digital health, and cloud-based analytics to provide a truly noninvasive solution. We are ecstatic to report that the FDA has approved Stomach Alimetry, making this novel test accessible to millions of Americans with persistent gastric discomfort.”
In a clinical context, the Gastric Alimetry test is conducted. Before and after a meal, patients record their symptoms using the Gastric Alimetry app while they are being recorded. The technology produces a high-resolution recording of digestion patterns from the skin’s surface and transmits clinical data over the cloud to aid in the diagnosis of stomach illnesses and facilitate individualized treatment. The system is indicated for common stomach disorders such as nausea and vomiting, gastroparesis, and functional dyspepsia, which affect over 8 percent of the world’s population and account for billions of dollars in healthcare costs.1,2 The test is also currently available in the United Kingdom and New Zealand. Dr. O’Grady said, “Diagnosing stomach complaints has proven to be a really tough clinical challenge.” “Existing diagnostics are usually faulty and inconclusive, and patients may endure months or even years of testing – sometimes expensive, intrusive, or requiring radiation – only to be left with confusion and trial-and-error treatment. Gastric Alimetry is a game-changing technology that will enable better clinical results, safer, more accessible and less-invasive treatment.”
Gastric Alimetry is the culmination of a decade of world-leading research and invention by an interprofessional team of doctors, engineers, designers, and scientists. “FDA approval of Gastric Alimetry solidifies Alimetry’s leading position in gastrointestinal wearables and noninvasive diagnostics,” Dr. O’Grady said. “Alimetry has an exceptional innovation pipeline, and this is the first in a succession of creative new features and solutions that have the potential to revolutionize the treatment of gastrointestinal function diseases.” The commercial availability of gastric alimetry will begin in July 2022. Visit www.alimetry.com for more details on Gastric Alimetry.
Alimetry receives FDA clearance for its flagship product Gastric Alimetry. (2022, June 15). MedTech Dive. Retrieved June 24, 2022, from https://www.medtechdive.com/press-release/20220614-alimetry-receives-fda-clearance-for-their-flagship-product-gastric-alimetry/