A mobile health care company can continue developing its app — after receiving a critical letter from the U.S. Food and Drug Administration.
Ideomed in Grand Rapids said today that its mobile health-management application, Abriiz, is considered a medical device by the FDA, but the app will not be subject to additional regulatory requirements for now and can integrate data from FDA-regulated medical devices, such as blood glucose monitors, with the app for caregivers and patients to manage chronic conditions.
Ideomed’s health care management app has been on the market since 2011, when it was initially targeted at severe pediatric asthma patients. Since then, Ideomed said that Abriiz said has sustained daily engagement by users, improved health outcomes and patient risk and reduced cost to insurers.
Keith Brophy, chief executive officer of Ideomed, said the FDA’s response to the company’s request was terrific news, and it’s great to see a friendly beacon coming from Washington in the entrepreneurial mobile health care industry.
“We were delighted when we received their feedback,” Brophy said. “It exceeds our expectations to have a response that provided such clarity and also is so affirming of the innovation that Ideomed is driving. We had anticipated that we might have to wait longer or travel through more of the process. At the same time, we are very confident our approach is sound, patient centered and very positive for the nation.”
In the FDA’s recent report defining its stance on mobile medical apps, it said the makers of health care products developed for mobile apps identified as a device — but posing minimal risk to patients and consumers — will not be expected to submit pre-market review applications or register their products with the FDA.
Brian Mack, director of marketing at Ideomed, said although the response isn’t an FDA approval of Abriiz, it validates the work Ideomed is doing.
“We have fallen in this very specific category . . . that says, based on your description, we don’t think you need additional oversight,” Mack said. “That is a pretty open and a welcome reaction to our innovation.”
Mack said the FDA response allows the company to move forward without additional cost and without additional delay to introduce new developments to the market.
Lisa Schutte, vice president of technology at Ideomed, said the added data-integration functionality to Abriiz will enhance the company’s ability to provide value to patients and care providers managing chronic conditions.
“The patient information provided by this expanded breadth of function . . . provides a more comprehensive picture of a patient’s health and condition,” Schutte said.
Brophy said the company will be able to leverage and support consumer health devices already in the market with the Abriiz application.
He added that the FDA’s stance marks the next level of sophistication of health care applications.
“It is so timely,” Brophy said. “We are literally seeing the evolution of our nation’s approach to mobile health and the integration of devices happening right now. We are very happy that we are able to play a role.”