Digital health company ResApp Health (ASX:RAP) has submitted a 510(k) premarket notification to the US Food and Drug Administration for SleepCheckRx, a prescription-only, software-as-a-medical device (SaMD) smartphone application for at-home sleep apnoea screening.
The targeted time period for the review of a 510(k) application by the FDA is 90 days.
SleepCheckRx is ResApp’s smartphone application that uses algorithms to assess a patient’s risk of obstructive sleep apnoea (OSA) by analysing breathing and snoring sounds during sleep. It requires no accessories or hardware other than a smartphone to make an assessment.
The company said that in a 308 patient, prospective clinical study, the SleepCheckRx algorithms were tested against an American Academy of Sleep Medicine Type II sleep study performed simultaneously in the patient’s home.
In the study, the algorithms identified patients with mild, moderate and severe OSA with a sensitivity of 85 per cent, 83 per cent and 83 per cent, respectively. The company said the algorithms had a specificity of 73 per cent, 80 per cent and 90 per cent, respectively.
SleepCheckRx would be made available to patients via a prescription from their healthcare provider.
Patients will be provided with a specific code allowing them to download SleepCheckRx from the App Store, with their results uploaded to a healthcare provider portal.
According to CEO and managing director, Dr Tony Keating, “This marks another important milestone for our sleep apnoea product line. Last year, we obtained TGA approval and CE Mark certification for our direct-to-consumer SleepCheck app which is now available in over 36 countries. This SleepCheckRx 510(k) submission is the first step in the review process with the FDA and we look forward to working with the FDA through the review to obtain clearance for SleepCheckRx.
"Sleep apnoea is a serious sleep disorder and research tells us that most people in the US with sleep apnoea don’t know they have it. With SleepCheckRx, physicians will have the opportunity to screen their patients conveniently and quickly for sleep apnoea, helping their patients take the first step in getting treatment.”