FDA allows Sentrian to market RPI mobile-health system

Sentrian said on Thursday that the Food and Drug Administration (FDA) has decided the company's Remote Patient Intelligence (RPI) mobile-health system meets the definition of a "medical device," on which the FDA intends to exercise "enforcement discretion."

The designation recognizes medical devices that are not subject to further FDA regulatory requirements "at the time" and enables Sentrian to begin marketing its RPI solution immediately in the U.S.

"We are encouraged by the FDA's well-balanced approach to nurturing innovation in (mobile health), while ensuring patient safety in their assessment process," Dean Sawyer, co-founder and CEO of Sentrian, said. "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."

Patients enrolled in adaptive research studies with Anthem’s Caremore Medicare Advantage Health Plan and other health care organizations are already using Sentrian RPI.

"This is a landmark for Sentrian and the industry, allowing unprecedented speed to continually deliver what patients and providers need,” Sentrian co-founder and Chief Medical Officer Jack Kreindler said. “Internally, we continue to build our technology to exceed the quality, security, privacy and safety-management standards required for tightly regulated medical devices. This gives our clients and patients the added confidence they demand and prepares us for the near future, when algorithmic decision support will steer personalized interventions, in advance of traditional evidence determining what's best for our patients."