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TRANSLATE

Thursday, September 22, 2016

Global Kinetics secures FDA clearance to market upgraded wearable for Parkinson’s disease patients

By STEPHANIE BAUM
September 22, 2016

Latest version of Global Kinetics’ KinetiGraph 


The U.S. Food and Drug Administration gave a green light to Australian medtech business Global Kinetics, which sought 510(k) marketing clearance for the latest version of its Parkinson’s disease mobility tracker, a news release noted. The new device considerably extends the length of time patients can wear the KinetiGraph, a spokeswoman for the company said.
The clearance comes two years after Global Kinetics secured marketing clearance for the first version of the device — the brainchild of neurologists at the Florey Institute of Neuroscience and Mental Health in Melbourne. The device is designed to precisely monitor, quantify and report movement symptoms of neurological diseases.
The latest iteration of the KinetiGraph is smaller and more compact than its predecessor. It more closely resembles a smartwatch than an activity tracker. The upgraded version includes a touch sensitive backlit screen with haptic and visual feedback, a water resistance enclosure and mobile charging and data handling capacity, according to the news release.
The device is designed to provide information to patients and physicians as well as pharmaceutical companies. It will be available to patients and physicians at movement disorder clinics in the U.S. starting in late September. But it also will support Global Kinetics’ clinical trial services businesses, and partnerships with pharma and device companies in the Parkinson’s disease space, the press release read.
Pharma companies and other organizations are interested in using wearables to gather data on patient activity between appointments, particularly for neurodegenerative conditions such as Parkinson’s disease. The insights gathered from these devices could also improve interactions between patients and physicians towards better managing these challenging conditions.
Photo: Bigstock 
http://medcitynews.com/2016/09/global-kineticswe-le-parkinsons-disease-monitoring/

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