Irritable Bowel Syndrome (IBS) is a disease that burdens patients with various debilitating symptoms, with a profound impact on their quality of life. Even though to date no exact cause can be pinpointed, while a suitable one-size-fits-all approach for treatment is not available, the disease is related to a miscommunication between the brain and the gut. Building upon this knowledge, DTx focusing on offering behavioral therapy, intend to provide patients with relief from their symptoms.
Currently, there are two FDA approved/cleared DTx for the treatment of IBS: Mahana IBS (formerly known as Parallel) and Regulora. Mahana IBS was approved in 2020 and followed the De Novo regulatory pathway, whereas Regulora was cleared in 2021 following the 510(k) regulatory pathway using Mahana IBS as predicate device. Both FDA submissions contained clinical performance data, which focused on the measurement of change in abdominal pain intensity. On average, it took the FDA 203 days to reach a decision, which is below the average of 238 days for all DTx.
So, let’s have a closer look at both:
For a more detailed overview, check out our report (download pdf below) in which we discuss the approval timeline, indications for use, and supporting evidence that enabled the FDA to approve/clear the currently available DTx in the gastroenterology space.
Any questions? Would you like to discuss DTx with us in more detail? Don’t hesitate to reach out to our team!