Respiri (ASX:RSH), an eHealth SaaS company supporting respiratory health management, has received 510(k) clearance from the US FDA for its wheezo device.
The company said it was able to secure a broad Indication for wheezo. It is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe, reported as WheezeRate in adults and children (2 years and older).
According to CEO Marjan Mikel, “The regulatory clearance of wheezo and our App in the United States represents a highly significant and major milestone for the company as we continue to expand our regulatory footprint for wheezo and enter substantial new markets.
"The FDA is one of the most stringent regulatory bodies in the world and this clearance further validates the efficacy and utility of our wheezo device and algorithm. To our knowledge the first time the FDA has cleared a device/mobile application for the detection, recording and changes of wheeze rates. This represents a step-change in technology for patients with respiratory wheeze seeking an effective, replicable and rapid device measurement and associated App that monitors this important measurement of lung function."
Asthma represents a significant disease burden in the US with approximately 8 per cent of the adult population and 7.5 per cent of children under the age of 18 living with the disease. This equates to 24.7 million people.
Respiri said its intends initially focus on the 60 per cent of children with persistent and severe asthma representing 3.3 million patients. It plans to launch in the US in the third quarter of 2022.