Nordic Kinetics Receives FDA 510(k) Clearance for Parkinson's Disease Monitoring
18.6.2026 14:02:57 CEST | Nordic Kinetics AB | Pressmeddelande
Nordic Kinetics AB has received 510(k) clearance from the U.S. Food and Drug Administration for its Sine Monitoring application, a software as a medical device (SaMD) running on Apple Watch that quantifies tremor and dyskinesia in adults with Parkinson's disease. It is the company's first FDA 510(k) cleared product on its Sine Monitoring platform for movement disorders.

The application measures the kinematics of Parkinson's disease symptoms during everyday activity and presents tremor and dyskinesia profiles over time, giving clinicians objective, continuous data to complement in-clinic assessment. The underlying algorithms were validated in a study of 343 patients with Parkinson's disease (Powers et al., Science Translational Medicine).
Parkinson's symptoms such as tremor and dyskinesia fluctuate over the course of a day, and brief clinic visits only capture snapshots of these. Continuous, objective measurement during everyday life can help clinicians see how a patient's symptoms vary and respond to treatment, supporting more informed decisions about medication and ongoing management.
Sine Monitoring is designed to turn the consumer smartphones and wearables that patients already own into tools for monitoring the symptoms of movement disorders. The Parkinson's disease application is the first product on the platform, with additional products in development.
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Nordic Kinetics AB is a medical technology company founded in 2025 based in Lund/Stockholm. It develops Sine Monitoring, a platform that turns the smartphones and wearables patients already own into clinical-grade monitors for movement disorders, capturing objective, continuous data to help clinicians and researchers understand how symptoms change over time.
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