- ResApp Health (RAP) submits a 510(k) pre-market notification to the US Food and Drug Administration (FDA) for its obstructive sleep apnoea platform
- The company says the FDA clearance would unlock a substantial market opportunity for ResApp
- The company aims to have the app made available to patients via a prescription from their healthcare provider, which would allow them to download SleepCheckRx from the App Store using a specific code
- Having already obtained Therapeutic Goods Administration (TGA) approval and CE Mark certification, the company is targeting an FDA review period of 90 days
- ResApp Heath was down 1.47 per cent, trading at 6.7 cents at 10:55 am AEDT
ResApp Health (RAP) has submitted a 510(k) pre-market notification to the US Food and Drug Administration (FDA) for its obstructive sleep apnoea platform.
The 510(k) premarket notification to the FDA was for SleepCheckRx, a prescription-only, software-as-a-medical device smartphone application for at-home sleep screening. The app analyses breathing and snoring sounds during sleep to assess a patient’s risk of obstructive sleep apnoea (OSA).
The submission follows a prospective clinical study involving 308 patients. This tested the SleepCheckRx algorithms against an American Academy of Sleep Medicine (AASM) Type II sleep study. The algorithms identified patients with mild, moderate and severe OSA, returning specificity of up to 90 per cent.
ResApp aims to have the app made available to patients via a prescription from their healthcare provider. Patients would be provided with a specific code, which would allow them to download SleepCheckRx from the App Store. Their results would then be uploaded to a healthcare provider portal.
The company said the FDA clearance would unlock a substantial market opportunity for ResApp.
“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,” CEO and Managing Director Tony Keating said.
“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,” Dr Keating added.
The company is targeting an FDA review period of 90 days.
ResApp Heath was down 1.47 per cent, trading at 6.7 cents at 10:55 am AEDT.