MetaMe Health Gains FDA’s 510(k) Clearance for Regulora for IBS Pain

MetaMe Health has received the FDA’s 510(k) clearance for Regulora, a smartphone app that provides behavioral therapy for patients with abdominal pain associated with irritable bowel syndrome.

The app delivers gut-directed hypnotherapy that helps patients with their symptoms by promoting healthier digestive tract function and delivering therapy designed to influence pain sensation.  

Prior to the development of Regulora, this type of therapy has been provided only in-person by licensed therapists, the company said.