The FDA has granted De Novo clearance to a prescription treatment for irritable bowel syndrome (IBS) from Mahana Therapeutics.
San Francisco-based Mahana Therapeutics’ Parallel uses cognitive-behavioral theory (CBT) to influence the communication between the brain and the gut to improve IBS, according to the company’s website.
The device classification section of the FDA’s website confirms that it made the decision to grant Mahana’s technology De Novo clearance on Nov. 25, nearly seven months after the company submitted for the classification on April 30.
Parallel was tested in a 558-subject, randomized, controlled trial in which, starting at three months, patients enrolled in a minimal-contact digital CBT program experienced a significant and clinically meaningful reduction in the severity of their IBS.
Additionally, after 12 months, Mahana observed that 66% of patients reported a significant and clinically meaningful reduction in the severity of their IBS, while the observed reduction in IBS severity was twice that of patients receiving medical care as usual.