FDA cleared Second Generation Parkinson’s KinetiGraph

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

Monitoring Parkinson’s symptoms at home

Parkinson’s disease is the second most common neurodegenerative disorder in the developed world, with around 60,000 people diagnosed in the U.S. each year.

Although there is no cure for the disease, there are treatments that can reduce the severity of a patient’s symptoms. But for these treatments to be effective, clinicians need a method to regularly monitor the patient’s symptoms in the home.

In a paper published today in the journal Scientific Reports, researchers at MIT and elsewhere describe a technique they have developed to monitor Parkinson’s disease progression as patients interact with a computer keyboard.

In this way the technique, which is based on technology originally developed to replace computer passwords, allows Parkinson’s signs to be monitored as people perform ordinary tasks such as typing emails or updating their Facebook status, according to Luca Giancardo, a former Catalyst Fellow in the Madrid-MIT M+Vision Consortium in the Research Laboratory of Electronics at MIT, and one of the paper’s lead authors.

“This approach uses something we do normally — interacting with a digital device — so it does not add any additional burden or take time away from daily activities,” he says.

Parkinson’s disease, which is caused by a loss of nerve cells in the brain leading to a reduction in levels of the chemical dopamine, is a progressive disorder with signs including tremors and motor difficulties, and ultimately severe disability and dementia.

Full Story can be found from MIT website.