Approvals


NeuroRPM announces FDA clearance for AI monitoring app for Parkinson’s disease on Apple Watch

NeuroRPM has announced that it has received clearance from the FDA for its NeuroRPM device, which uses AI and existing Apple Watch technology to monitor symptoms of Parkinson’s disease, offering continuous, day-to-day tracking of symptoms.

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The technology can continuously and passively track bradykinesia, tremor and dyskinesia, which are the predominant symptoms of Parkinson’s disease. When integrated into an Apple Watch app, the technology can passively collect this data throughout a patient’s daily life with little interruption. The app is now available to patients via a prescription.

Dr Alexander Ksendzovsky, director of functional neurosurgery at the University of Maryland, commented: “The clearance of NeuroRPM is a major milestone in the fight against

Parkinson’s disease. This technology will allow for unprecedented insights into the symptoms of Parkinson’s disease including bradykinesia, tremor and dyskinesia, using critical health and wellness data from Apple Watch. NeuroRPM is able to assess even slight changes with accuracy comparable to that of a neurologist. This changes the game for the treatment of Parkinson’s patients.”

Atila Omer, NeuroRPM’s president, added: “We are thrilled to be on the new frontier of digital health with NeuroRPM. By leveraging the power of Apple Watch, we are transforming the way individuals with Parkinson’s disease understand their health, enabling care providers to make more informed clinical decisions which will lead to better health outcomes. We are honoured to help drive this revolution in healthcare.”