Therapy Areas: Devices
FDA Grants 510(k) Clearance to Onera STS, a System for At-Home and In-Lab Polysomnography Studies
28 April 2022 - - US- and Netherlands-based sleep medicine and remote monitoring specialist Onera Health's Onera B.V. Dutch subsidiary has received 510(k) market clearance from the US Food and Drug Administration for its system for Polysomnography studies, Onera STS, paving the way for widespread deployment of the patch-based technology across healthcare systems in the US, the company said.

The FDA determined that Onera's product was substantially equivalent to a system widely used in today's in-lab PSG studies, marketed by the medical device manufacturer Natus Medical Inc.

Onera's clinical-grade technology is a huge step forward in transforming the outdated, cumbersome, and expensive process of traditional sleep testing, which is partly responsible for the underdiagnosis of sleep disorders.

Onera STS patch-based product, in combination with Onera's Digital Health Platform, supports the company's PSG end-to-end service that enables and simplifies clinical-grade sleep studies with no upfront investment at a fixed fee per test.

The company said that Onera's end-to-end solution's commercial launch in Europe is scheduled for the second half of the year, with plans to extend it with selected partnerships to the American market, before commercializing it broadly in 2023.

Onera Health will present its latest clinical study results at SLEEP 2022, from 4th-8th June 2022 in Charlotte, NC.

Onera has offices in the Netherlands and the US.