Global Kinetics Corp said today it won FDA 510(k) clearance for its next-gen wrist-worn personal kinetigraph system.
The device is designed to record movement symptoms of Parkinson’s and provides medication reminders and aid in making assessments about response to medication, the Melbourne, Australia-based company said.
“Our new second generation PKG represents the most recent milestone in our continued focus on development and marketing of products and services to meet the needs of the Parkinson’s community worldwide. With advanced monitoring technology and smart design, this device can play a significant role in improving care for patients, care partners and healthcare providers in the years ahead,” prez & CEO Timothy Still said in a press release.
The next-generation PKG system is smaller and includes a touch sensitive, backlit screen with haptic and visual feedback as well as a water resistant enclosure and mobile charging and data handling capabilities, Global Kinetics said.
The company said that the new device can also “provide important insights about the patient experience to care partners and to drug companies working to better understand Parkinson’s and shape future clinical research programs.”
“The second generation PKG platform also enables us to capitalize 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. Global Kinetics continues to achieve year-to-year growth by delivering on our strategic business objectives and our commitment to make a meaningful difference for people with Parkinson’s. We recently celebrated delivery of our 11,000th PKG movement recording, and we look forward to achieving new levels of support for the patients we serve with our Second Generation PKG system,” CEO Still said in prepared remarks.
Global Kinetics Corp said the device will be available in the U.S. in late September. The device is pending CE Mark regulatory approval in the European Union, with an expected clearance late this year.