FDA approves remote patient monitoring device

Sentrian, a remote patient intelligence (RPI) company uses remote biosensors and machine learning to detect patient deterioration early

Sentrian, recently received confirmation from the Food & Drug Administration (FDA) that its RPI solution meets the definition of a medical device for which the FDA intends to exercise ‘Enforcement Discretion’.

The designation means Sentrian can immediately begin marketing its RPI solution in the US.

The Sentrian RPI platform allows clinicians to rapidly build new remote disease deterioration models. This could lead to less preventable hospitalisations by detecting patient deterioration early before it becomes acute.

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

"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.