The FDA recently granted 510(k) clearance to market H20 therapeutics‘ prescription-only Parky App for the Apple Watch smart watch. In a longitudinal study published in Science Translational Medicine, the app has promise as technology to support patient-client communication, medication titration, and clinical trial design. The study’s 14 authors are primarily Apple, Inc. employees, but also include personnel associated with Harvard Medical School, the Silicon Valley Parkinson’s Center, and the Parkinson’s Disease and Movement Center of Silicon Valley.
The FDA granted H20 Therapeutics 510(k) clearance to market Parky App for monitoring Parkinson’s disease. The primary functions are to communicate data and give feedback that clinical professionals can use to optimize treatment plans when patients don’t have face-to-face physician-patient meetings in an office. The app monitors tremors and dyskinesia (involuntary movements of the face, trunk, and extremities) that the Apple Watch tracks and reports in real time.
Parky App is not a therapeutic, but is cleared as a communications tool so that physicians can observe data from real life settings and not just while a patient is in a doctors’ office or clinic.
