Onera BV has received US Food and Drug Administration (FDA) 510(k) market clearance for its patch-based Onera STS system for in-lab Polysomnography (PSG) studies.
The latest approval paves the way for the extensive deployment of the technology across US healthcare systems.
As determined by the FDA, Onera STS was substantially equivalent to a system that is currently widely used for in-lab PSG studies, which is marketed by Natus Medical.
Onera founder and CEO Ruben de Francisco said: “The last two years caused a behavioural 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.”
When used with Onera’s Digital Health Platform, the new patch-based product supports the company’s PSG end-to-end service.
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This enables simplified clinical-grade sleep studies without the need for upfront investment at a fixed fee for a test.
Hospitals with limited or no access to a sleep clinic will also get an opportunity to implement diagnostic testing within their institution with Onera’s user-centric technology, which also supports at-home diagnostics.
Francisco continued: “Our end-to-end solution has the potential to improve the sleep and ultimately overall health of millions of patients.”
The company plans to commercially launch the solution in Europe during the second half of the year.
Prior to the commercialisation of Onera STS in 2023, it will be extended to the US market with selected partnerships.