Onera Health announced today that it received FDA 510(k) clearance for its Onera STS system for polysomnography (PSG) studies.
Eindhoven, The Netherlands-based Onera’s patch-based technology aims to transform the outdated, cumbersome and expensive process of traditional sleep testing.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-to-end system in Europe in the second half of this year. The company expects to extend the launch with selected partnerships to the American market before broad commercialization begins in 2023.
“Achieving FDA clearance is an exciting and critical milestone to our commitment to helping our customers deliver better access to care for their patients,” Onera founder and CEO Ruben de Francisco said in the release. “The last two years caused a behavioral shift and widespread acceptance of at-home diagnostics as both patients and medical professionals sought quality solutions that deliver reliable results.
“Receiving the FDA 510(k) clearance demonstrates that our non-invasive, compact, and portable medical device offers the comprehensive data that is required to support the diagnosis of sleep disorders, whether at the patients’ home or in the clinic.”