Itamar Medical, which develops and markets non-invasive diagnostic medical devices for sleep-related breathing disorders, received Food and Drug Administration (FDA) clearance to expand the medical indication of WatchPAT for sleep apnea diagnosis. Under this approval, the use of WatchPAT in the United States is permitted from the age of 12, expanding the previous indication for ages 17 and older. The new clearance is expected to increase the target market for WatchPAT. Similar approvals were recently granted in Japan and Europe.
WatchPAT is a home sleep test (HST) diagnostic device for sleep apnea. “We are excited by the FDA’s decision to approve an expanded age indication for our WatchPAT. This clearance is a testament to the solid scientific foundations of our product, as well as to the increasing demand for its use,” says Gilad Glick, CEO of Itamar Medical, in a release.
In many cases, adolescents will suffer from various comorbidities, such as ADHD, that will not receive appropriate medical care as long as the underlying sleep apnea remains undiagnosed and untreated. Early diagnosis of sleep apnea not only enables appropriate and effective treatment of the problem, but also precludes unnecessary use of medication, hence optimizing patient safety and treatment outcomes.
David Gozal, MD, pediatric sleep physician and scientist at the University of Chicago and Comer Children’s Hospital in Chicago and president of the American Thoracic Society, adds: “The clearance of the WatchPAT for clinical use in adolescents is a welcome addition to the currently limited array of home-based diagnostic technologies for children suspected to suffer from sleep-disordered breathing, and should enable reliable and more timely detection of those patients in need for treatment.”