FDA Clears Expanded Indication For Itamar Medical Inc.'s WatchPAT Sleep Apnea Diagnostic Device For Adolescents
WatchPAT approved for diagnostic testing on patients as young as twelve, which will increase the size of the product’s target population in the USA
CAESAREA, Israel, July 27, 2016 – Itamar Medical, which develops and markets non-invasive diagnostic medical devices for sleep-related breathing disorders, received FDA clearance to expand the medical indication of WatchPAT for sleep apnea diagnosis. Under this approval, the use of WatchPAT in the USA is permitted from the age of twelve, expanding the previous indication for ages seventeen 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. The product is a central pillar in Itamar Medical’s strategy of providing a Total Sleep Solution (TSS), which includes diagnostics and treatment of 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 foundation of our product, as well as to the increasing demand for its use," said Gilad Glick, CEO of Itamar Medical.
The incidence of sleep apnea increased significantly in recent years, reaching alarming rates among adolescents. This is attributed, among other factors, to the increase in obesity in this age group.
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. Studies show that 25% or more of ADHD cases in adolescents can be attributed to untreated sleep apnea. 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.
Eitan Kurtz, Director of the sleep clinic at the Mor Institute said, "We welcome the approval to use the WatchPAT home sleep test among adolescents. This approval will allow us to continue to treat a variety of sleep disorders among all age groups, and offer diagnosis, treatment and optimized follow-up over time."
Professor Giora Pillar, Director of Sleep at Clalit Health Services in Haifa and Head of the pediatrics department at Carmel Hospital added, "Pediatric sleep disorders are very common. Teens with sleep disorders tend to suffer from more infectious diseases, metabolic and neurodevelopmental disorders, and have lower academic achievement."
CAESAREA, Israel, July 27, 2016 – Itamar Medical, which develops and markets non-invasive diagnostic medical devices for sleep-related breathing disorders, received FDA clearance to expand the medical indication of WatchPAT for sleep apnea diagnosis. Under this approval, the use of WatchPAT in the USA is permitted from the age of twelve, expanding the previous indication for ages seventeen 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. The product is a central pillar in Itamar Medical’s strategy of providing a Total Sleep Solution (TSS), which includes diagnostics and treatment of 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 foundation of our product, as well as to the increasing demand for its use," said Gilad Glick, CEO of Itamar Medical.
The incidence of sleep apnea increased significantly in recent years, reaching alarming rates among adolescents. This is attributed, among other factors, to the increase in obesity in this age group.
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. Studies show that 25% or more of ADHD cases in adolescents can be attributed to untreated sleep apnea. 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.
Eitan Kurtz, Director of the sleep clinic at the Mor Institute said, "We welcome the approval to use the WatchPAT home sleep test among adolescents. This approval will allow us to continue to treat a variety of sleep disorders among all age groups, and offer diagnosis, treatment and optimized follow-up over time."
Professor Giora Pillar, Director of Sleep at Clalit Health Services in Haifa and Head of the pediatrics department at Carmel Hospital added, "Pediatric sleep disorders are very common. Teens with sleep disorders tend to suffer from more infectious diseases, metabolic and neurodevelopmental disorders, and have lower academic achievement."