Global Kinetics gets FDA okay for Parkinson’s KinetiGraph
Australia-based Global Kinetics has received 510(k) marketing clearance from the FDA for its next generation, wrist-worn Parkinson’s KinetiGraph (PKG) System.
The new PKG technology enables a shift to “anywhere, anytime” monitoring 24/7/365 as well as data capture for people with Parkinson’s disease.
In a statement, CEO, Timothy Still, said the new PKG technology is a core platform for the company to reach scale in the US, European and Asia Pacific clinical care markets.
“The second generation PKG platform also enables us to capitalize on our growing telehealth and clinical trial services businesses, and to build on our already substantial partnerships with global pharmaceutical and device leaders in Parkinson’s,” he added.
The second generation PKG is smaller, more compact and includes a touch sensitive backlit screen with haptic and visual feedback, a water resistance enclosure and mobile charging and data handling capacity.