The US Food and Drug Administration (FDA) has said that Ideomed’s mobile health app Abriiz meets the definition of a medical device for which the agency intends to exercise Enforcement Discretion.
Abriiz has been categorized by the FDA categorized under the enforcement discretion parameters of its recent mobile medical applications guidance, informing the company that mobile health app is not subject to further FDA regulatory requirements at this time.
Acording to Ideomed, the FDA clears the way for Abriiz to be connected to other agency-regulated devices including blood glucose monitors, pulse oximeters, scales and blood pressure cuffs.
Ideomed Technology vice president Lisa Schutte said that the patient information provided by this expanded breadth of function, combined with the medication adherence, activity-tracking and health symptom data already captured by Abriiz provides a more comprehensive picture of a patient’s health and condition.
"This enhances our ability to provide value to patients and care providers managing chronic conditions such as heart disease, diabetes, COPD and asthma," Schutte added.
It also affirms Ideomed’s mission to improve the quality of life for the people we serve."
Abriiz has been in the market since 2011. The app has already been used in clinical trials and other implementations that have reported sustained daily engagement, improved health outcomes such as fewer emergency room visits, improvements in patient risk level stratification and reduced costs to insurers.
Image: Abriiz by Ideomed receives word it can link to FDA-regulated medical devices. Photo: Courtesy of PRNewswire/Ideomed, Inc.