Global Kinetics gets FDA clearance for PKG
Global Kinetics Corporation has secured FDA clearance for its Parkinson’s KinetiGraph (PKG) mobile health device, paving the way for its sale in the US.
PKG is a wrist-worn device for monitoring the movement-based symptoms of Parkinson’s disease. It has already been approved in Europe and Australia and is available in nine markets. It will now be made available in key US clinics within weeks.
The technology was originally developed at Melbourne’s Florey Institute of Neuroscience and Mental Health.
Global Kinetics managing director Andrew Maxwell said securing FDA clearance has been an “an important step” for the company.
“We are working closely with leading US neurologists and have already made excellent progress recruiting key reference sites to make the PKG available in the USA,” he said. “The US market is the next frontier [for the technology].”
He said the company has more expansion plans on the cards and expects that Parkinson’s patients in 30 countries worldwide will have access to the PKG within 18 months.
Word of the FDA’s decision comes days after US-based IT giant Intel teamed up with the Michael J Fox Foundation to develop wearable devices for monitoring Parkinson’s symptoms.
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