Sentrian has recently received FDA’s confirmation that its Remote Patient Intelligence (RPI) solution meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.”
Said designation identifies medical devices that “are not subject to further FDA regulatory requirements at this time” and clears the way for Sentrian to immediately begin marketing its RPI solution broadly in the U.S.
“We are encouraged by the FDA’s well-balanced approach to nurturing innovation in mHealth while ensuring patient safety in their assessment process,” said Dean Sawyer, Co-Founder and CEO of Sentrian. “The FDA’s decision enhances our ability to provide value to patients and care providers managing chronic conditions such as heart disease, complex diabetes, and COPD by increasing our product development speed and agility. It also affirms Sentrian’s mission to improve the quality of life for the patients we serve.”
Sentrian RPI is already being used by patients enrolled in adaptive research studies with Anthem’s Caremore Medicare Advantage Health Plan and other healthcare organizations. By leveraging data collected by biometric devices and machine learning, it is able to detect actionable health deterioration early and help reduce preventable hospitalization in patients with complex chronic disease.