Digital IBS care startup metaMe Health is launching its recently FDA-approved prescription digital therapeutic using a partnership with operations and commercialization company Indegene.
Regulora, which scored an FDA 510(k) late last year, delivers gut-directed hypnotherapy to help alleviate pain associated with IBS in adults. As part of the commercialization deal, Indegene will focus on bringing...
The German Federal Institute für Drugs and Medical Devices (BfArM) has added a new digital therapeutic to its digital health applications (DiGA) directory for public reimbursement.
Cara Care is the first DiGA that addresses gastroenterological issues and widespread digestive health problems such as Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), food and reflux intolerances.
The...
metaMe Health has received FDA 510(k) clearance for Regulora, a prescription digital therapeutic aimed at treating abdominal pain associated with irritable bowel syndrome in adults.
Regulora is a smartphone app that delivers behavioral therapy based on gut-directed hypnotherapy to alleviate IBS pain.
“The FDA’s clearance of Regulora, our first PDT, is a major achievement for the company,” Tim...
Bold Health, a London-based company developing digital therapeutics for gastrointestinal conditions, is backing a new University of Pennsylvania-led study that will directly compare the company's cognitive behavior therapy (CBT) app for irritable bowel syndrome (IBS) to Headspace's consumer mindfulness and meditation app.
According to a clinicaltrials.gov listing spotted by Exits & Outcomes,...
Editor's note: This story has been updated with quotes and additional information from Mahana's CEO and cofounder.
The FDA has granted a De Novo clearance to San Francisco-based Mahana Therapeutics' Parallel, a prescription digital therapeutic for patients with irritable bowel syndrome (IBS) that delivers cognitive behavioral therapy (CBT).
The agency made its decision on November 25, according...
NHS TAYSIDE LAUNCHES NEW INHEALTHCARE APP
NHS Tayside is launching a new app in partnership with Inhealthcare to help people suffering from IBS.
The new app has been funded by the Scottish Government’s Technology Enabled Care Programme and the Modernising Patient Pathways Programme.
The app will help people to track their symptoms over time and identify any changes. They can request extra...
Sanofi has announced this week that it is supporting a three-month pilot to facilitate access to an online symptom checker from British company Babylon for people concerned about digestive health issues.
The service can be accessed through the Buscopan and Dulcolax websites, Sanofi’s over the counter digestive health products.
The pharma giant is understood to have launched a similar initiative...
A new company out of London called Bold Health is combining digital tools and cognitive behavioral therapy with the aim of helping patients improve their gut health.
Earlier this month, the company launched its first product, Zemedy, an app targeted at treating irritable bowel syndrome symptoms through a combination of CBT, hypnotherapy exercises and stress management techniques.
“There is a...
Chicago-based metaMe Health, a startup focused on behavioral digital treatments gastrointestinal conditions, has raised $3.8 million in seed funding. LionBird Ventures led the round, which also saw contributions from Hemi Ventures and other unnamed backers.
WHAT THEY DO
The company’s lead product is Regulora, a treatment tackling the cognitive, behavioral and affective factors that can trigger...
The FDA has granted De Novo clearance to a prescription nerve stimulation device for the reduction of functional abdominal pain. The device is intended for use by adolescents and teens with irritable bowel syndrome in combination with other therapies.
Developed by Innovative Health Solutions, the IB-Stim devices is a single-use electrical nerve stimulator. When placed behind the patient’s ear, it...
