www.fdanews.com/articles/177722-fda-backs-expanded-indication-for-sleep-apnea-diagnostic-device
FDA Backs Expanded Indication for Sleep Apnea Diagnostic Device
July 28, 2016
Itamar Medical received FDA clearance to expand the indication of their sleep apnea diagnostic device to include younger patients.
The tool is now approved for use in patients as young as 12. It previously had been approved only for use in patients 17 and older.
Similar approvals already have been granted in Europe and Japan. — Cynthia Jessup