FDA Opens Door for Sentrian to Market Across US

FDA Opens Door for Sentrian to Market Across USSentrian has received important FDA accreditation for its namesake remote care system. The regulatory agency has deemed the Sentrian Remote Patient Intelligence (RPI) solution a “medical device” over which the FDA will exercise “Enforcement Discretion”, which means that it is “not subject to further FDA regulatory requirements at this time”. And that means that Sentrian can now go ahead and start marketing its RPI solution across the US.

The Sentrian RPI solution uses a combination of machine learning and biometric sensors to track patients’ health issues, with a particular focus on chronic disease. The system allows for cloud-based patient monitoring, allowing health professionals to monitor even large groups from afar. It’s designed to reduce hospitalization rates as much as possible, and to see just how much potential there is for such a lofty goal, Sentrian recently embarked on a year-long study to observe its benefits in a thousand-patient trial. Meanwhile, the American Telemedicine Association (ATA) has recognized its promise, awarding it the 2015 President’s Award for Innovation in Remote Health Care.

The FDA development is to some extent the product of a relaxation of its regulatory approach. In February of this year it released a Mobile Medical Applications report in which it suggested that it would assess new mobile medical devices based on risk, and exercise enforcement discretion in those cases where the risk to patients is minimal. In a statement, Sentrian CEO Dean Sawyer commended the FDA’s “well-balanced approach to nurturing innovation in mHealth while ensuring patient safety in their assessment process.”