Valley View-based Great Lakes NeuroTechnologies have received TGA approval to market their Kinesia technology in Australia. The product line includes patient-worn motion sensors and a tablet computer to quantitatively assess tremor, bradykinesia, and dyskinesia associated with Parkinson’s disease and in response to treatments.
Market applications include both in-clinic and home-based telemedicine patient care, assistance in programming deep brain stimulation, and providing quantitative endpoints to determine efficacy in clinical trials.
“Achieving TGA certification to market in Australia represents our commitment to delivering innovative, high quality medical technology and increasing our growth in international markets,” said Dave Tucholski, director of Quality and Regulatory Affairs. “This expands upon our previous regulatory successes including FDA clearance, CE Mark, and ISO certification.”
