The 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 US.
On February 9, 2015 the FDA released a Mobile Medical Applications report announcing it would take a tailored, risk-based approach to regulating medical devices, with a focus on the small subset of technologies that meet the regulatory definition of "device."
For the many mobile and cloud-based applications that the FDA deems a "device" but which pose minimal risk to patients and consumers, the agency will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or register their products.
"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."
Dr. Jack Kreindler, Sentrian’s Founder and Chief Medical Officer, added, "This is a landmark for Sentrian and the industry allowing unprecedented speed to continually deliver what patients and providers need.
"Internally we continue to build our technology to exceed the quality, security, privacy and safety management standards required for tightly regulated medical devices."
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.
Sentrian’s cloud-based technology leverages the revolution in biometric devices and machine learning with the intention of detecting actionable health deterioration early and with higher accuracy, helping to reduce preventable hospitalization in patients with complex chronic disease.
