US-based Ideomed has received notice from the US Food and Drug Administration (FDA) that its mobile health app Abriiz meets the definition of a ‘medical device’, clearing the way for it to connect with other authorised devices.
The designation identifies mobile medical devices that ‘are not subject to further FDA regulatory requirements at this time’.
Approval clears the way for Abriiz to be connected to other FDA-regulated devices including blood glucose monitors, pulse oximeters, scales and blood pressure cuffs.
The FDA’s recent mobile medical applications report showed that its stance would be to take a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of ‘device’.
Ideomed vice-president of technology Lisa Schutte said: "This enhances our ability to provide value to patients and care providers managing chronic conditions such as heart disease, diabetes, COPD and asthma."
FDA 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.
Abriiz has been on the market since 2011 and it has sustained daily engagement by users, improved health outcomes and patient risk and reduced cost to insurers.
ACT|The App Association executive director Morgan Reed said: "Ideomed’s Abriiz solution has already demonstrated dramatic success in early clinical trials. Helping patients better manage their chronic conditions means better health outcomes and lower costs for everybody."
Image: Abriiz by Ideomed receives word it can link to FDA-regulated medical devices. Photo: courtesy of PRNewsFoto/Ideomed.