Parkinson’s assessment devices from Great Lakes NeuroTechnologies receive TGA approval

Jan 10 2013

Great Lakes NeuroTechnologies announced that they received TGA approval to market Kinesia technology in Australia. The Kinesia™ 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. Physicians utilize a web interface to setup patient studies and track symptom responses. 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, Quality and Regulatory Affairs. “This expands upon our previous regulatory successes including FDA clearance, CE Mark, and ISO certification for our Kinesia systems.”

As international adoption of Kinesia technology continues to grow, Australia represents a unique opportunity. According to research, the incidence of Parkinson’s in Australia has grown 17% over the last 6 years, with 1 in 350 Australians now living with the disease. This market, coupled with the need for telemedicine tools in the region to improve care for remote populations, provided a driver for entering the Australian market. Kinesia’s infrastructure includes several key technology features for telemedicine and clinical trials. The patient take-home kit supports broadband data transfer directly from a patient’s home to a secure server. This allows physicians and researchers immediate, online access to real-time symptom reports and video diaries. Next, miniature, patient-worn motion sensors are integrated with wireless communications. This minimizes setup time and patient burden during home-based assessments. Finally, physicians and researchers can use their own tablets, or any smart mobile device or computer, to view web-based reports. Color-coded mapping provides intuitive, quantitative tools to document symptom severity and motor fluctuations.

For the last decade, Great Lakes NeuroTechnologies has been the worldwide leader in developing quantitative, home-based assessment tools for Parkinson’s disease. Fueled by strong funding support from the National Institutes of Health in the United States, including the National Institute of Neurological Disorders and Stroke and the National Institute on Aging, Kinesia HomeView has been commercialized and clinically validated in numerous studies and with hundreds of patients. Great Lakes NeuroTechnologies will be showcasing the technology at the Movement Disorders Society conference in Sydney, Australia in June 2013.

About Great Lakes NeuroTechnologies

Great Lakes NeuroTechnologies is committed to pioneering innovative biomedical technologies to serve research, education, and medical communities, improving access to medical technology for diverse populations, and positively impacting quality of life for people around the world.