Michigan medical app maker Ideomed will get to dodge FDA review for its medical app, allowing the company to save a lot of time and money in reaching a larger audience.
Ideomed’s Abriiz aggregates data from health and fitness devices, keeps track of users’ daily medication and personal health routines, provides alerts to patients and their caregivers and allows doctors to communicate with patients and customize treatment regimens through the app.
The FDA categorized the app under the "enforcement discretion" parameters of its recent mobile medical applications guidance, informing Ideomed that Abriiz is "not subject to further FDA regulatory requirements at this time." The designation is generally reserved for mobile applications that the FDA deems a minimal risk to patients, allowing developers to bypass premarket review requirements.
"We are encouraged by the FDA’s well-balanced approach to encouraging innovative development in mHealth while rightfully ensuring the nation’s safety in their assessment process," Ideomed CEO Keith Brophy said in prepared remarks. "The FDA’s response to our request affirms our expectation that the manner in which Abriiz surfaces consumer health device data is on the mark."
The app has been on the market since 2011 and has been tested in clinical trials, according to an Ideomed press release. Researchers found that the app was associated with "sustained daily engagement, improved health outcomes such as fewer emergency room visits, improvements in patient risk level stratification and reduced costs to insurers."