Eindhoven, The Netherlands-based Onera’s patch-based technology aims to transform the outdated, cumbersome and expensive process of traditional sleep testing.
Onera said in a news release that its clinical-grade technology can offer an upgrade on the traditional sleep testing process that “is partly responsible” for the underdiagnosis of sleep disorders. The FD determined that the Onera STS system was “substantially equivalent” to the widely-used system for in-lab PSG studies that Natus Medical markets.
The newly cleared system combines with Onera’s digital health platform to support an end-to-end PSG service that enables and simplifies clinical-grade sleep studies with no upfront investment at a fixed fee per test.
Onera has planned a commercial launch for the end-…