UK medtech startup Acurable has gained FDA clearance for a novel wireless diagnostic device for remote detection of obstructive sleep apnea (OSA). A formal launch into the US market is slated to follow this summer. Its wearable is already being used by a number of hospitals in the UK (where it launched in 2021) and in the European Union, after obtaining local regulatory clearances in the region.
The startup, which was founded back in 2016, is the brainchild of Imperial College professor Esther Rodriguez-Villegas, director of the university’s Wearable Technologies Lab, who spent some 1.5 decades conducting research into using acoustic sensing for tracking respiratory biomarkers to diagnose cardiorespiratory conditions — work that underpins the commercial hardware.
The London-based startup raised an €11 million Series A round (~$11.8M) back in October with its eye on the US launch. Prior to that it r...