Brisbane, Australia-based ResApp has claimed a 510(k) clearance for SleepCheckRx as a prescription-only digital therapy in the software-as-a-medical device (SaMD) category, clearing the path for a commercial launch in the US. It is already approved in Australia and Europe.
Pfizer’s Australian unit made an offer to buy ResApp in April that valued the company at around A$100 million ($75 million), seeking ownership of a portfolio of apps that use artificial intelligence algorithms to both diagnose and measure the severity of respiratory diseases, and has since raised its bid to around A$127 million.
