Global Kinetics Corporation has received notification from the US Food and Drug Administration of 510 (k) marketing clearance for its second generation technology – the PKG™-Watch.
Clearance of this technology signals a major milestone for Global Kinetics, underpinning aggressive expansion into new product and service offers to meet the needs of the Parkinson’s community worldwide.
The new technology is a core platform for the company to reach scale in the US, European and Asia Pacific clinical care markets by overcoming previous distribution and data handling constraints. It enables GKC to capitalise 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.
Developed based on extensive feedback from users of the previous-generation PKG™, 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.
Source: Global Kinetics Corporation