Friday, July 3, 2026

FDA approves digital therapy for IBS abdominal pain


Irritable bowel syndrome is one of the most common gastrointestinal diseases, which is Estimated to affect approximately 10% of adults In the United States, this disease, which is characterized by abdominal pain, bloating, diarrhea, or constipation, has different triggers for each patient. For example, certain foods, stress, and other factors can cause the onset of symptoms.

MetaMe Health is a startup company that builds app-based treatments to help relieve some of these symptoms. Recently received FDA clearance Because of its digital therapy called Regulora.it is Built around research Olafur Palsson, a psychologist at the University of North Carolina, studies the use of psychotherapy for IBS and other gastrointestinal diseases. Although the exact cause of IBS is unclear, one idea is that the connection between the brain and the gut can cause symptoms.

The app uses self-directed hypnotherapy, designed to get people into a state of relaxation and create a sense of relief around their conditions and symptoms. It is intended to be used in combination with other treatments, including dietary changes or medications.

Treatment consists of 7 30-minute behavioral therapy over a 12-week period. The FDA cleared it based on data from a randomized controlled trial of 362 people, half of whom used Regulora for 12 weeks, and the control group used a digital program for muscle relaxation therapy.

Four weeks after treatment, abdominal pain improved in both groups, but there was no statistically significant difference between the treatment group and the control group. However, in the last 4 weeks of treatment, 30.9% of Regulora subjects experienced an improvement in the intensity of abdominal pain, compared to 21.5% in the control group.

Other companies are also working on digital therapy for IBS.For example, Parallel, it is Approved by the FDA a year ago, Also focused on the use of cognitive behavioral therapy for IBS.At the same time, start Oshi Health recently raised $23 million Its virtual care platform connects patients with gastroenterologists, nutritionists, mental health providers and health coaches to help them manage gastrointestinal diseases.

Photo: Getty Images, photo_chaz



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