Wearable tracker for Parkinson’s disease gets FDA nod

Yet another clinically-focused, activity tracking wearable has now been cleared by the FDA, this one aimed specifically at the monitoring and treatment of Parkinson’s disease. The Personal KinetiGraph, from Melbourne, Australia-based Global Kinetics Corporation, “offers comprehensive, automated reporting of a Parkinson’s disease patient’s movements so that neurologists and other

physicians can more easily identify changes in movement symptoms to assist in decisions to optimize therapy,” according to the company.

“Monitoring changes in a patient’s movement symptoms is a critical element in the treatment of Parkinson’s and many other movement disorders, but it can be difficult for both patients and healthcare providers to identify and assess changes in movement symptoms effectively,” Andrew Maxwell, managing director and CEO of Global Kinetics Corporation, said in a statement. “The Personal KinetiGraph provides clinicians with a clear and accurate assessment of the patient experience outside of office visits and examinations.” 

The wrist-worn device is already in use in Australia, but has previously not been cleared for sale in the United States. The device can be prescribed to a Parkinson’s patient by their physician; the patient then takes the device and wears it at home. It can collect and store up to 10 days of movement data. That data is then downloaded by the physician, who can use it to obtain a more accurate assessment of the patient’s mobility than they could get from an office visit.

The device can also serve as a medication adherence tool in conjunction with the Parkinson’s symptom management medication levodopa. The wearable can be set to vibrate at preset times to remind patients to take the medication.

Like most movement tracking in clinical settings, the status quo is in-lab tests and patient self-reporting, a vexing situation as Parkinson’s symptoms vary widely from patient to patient. Neurologists at the Florey Institute of Neuroscience and Mental Health in Melbourne developed the software and hardware in 2007 to try to improve the situation.

“In many cases when we discuss changes in movement symptoms with Parkinson’s patients, they are unable to recall specific information that can help doctors understand whether their disease is progressing and, if so, how rapidly,” Dr. Malcolm Horne, chief scientific officer and co-founder of Global Kinetics Corporation, who developed the technology with Dr. Robert Griffiths at the Florey Institute, said in a statement. “This technology brings clinicians a whole new level of accurate information to support more effective and timely treatment decisions.”

In February of this year, the FDA cleared two wristworn activity trackers from British company Camntech: non-smartphone-connected, but highly accurate devices intended for use in clinical trials.  In July, Australian company dorsaVi followed suit, obtaining clearance for its ViMove sensor system for detailed activity tracking. Meanwhile, Orthocare Innovations, a company that has long held FDA clearance for its StepWatch device, created a spin-off company called modus health to market their device, hitherto used mainly for research purposes, to clinicians. MobiHealthNews covered the trend in an in-depth report last month.