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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.-------- English Version ------------
Nordic Kinetics AB has obtained FDA 510(k) clearance for its Sine Monitoring app on Apple Watch, which measures tremor and dyskinesia in adults with Parkinson's disease. It is the company's first FDA-cleared product on the Sine Monitoring platform for movement disorders.-------- Link if available ----------
https://www.nordickinetics.com