The US Food & Drug Administration (FDA) has granted 510(k) market clearance to Onera STS [sleep study system], paving the way for widespread deployment of the patch-based technology across healthcare systems in the United States. The FDA determined that Onera’s product was substantially equivalent to a polysomnography (PSG) system marketed by Natus Medical Inc.
“Achieving FDA clearance is an exciting and critical milestone to our commitment to helping our customers deliver better access to care for their patients,” says Ruben de Francisco, founder and CEO of Onera, in a 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.”
Onera STS patch-based product, in combination with Onera’s Digital Health Platform, supports the company’s PSG end-to-end service that enables clinical-grade sleep studies with no upfront investment at a fixed fee per test.
“Our service helps to remove the most burdensome physical, scheduling, and financial barriers that have traditionally challenged access to professional sleep diagnosis and treatment in the past. The user-centric technology supports not only at-home diagnostics but also offers opportunities for hospitals that have limited or no access to a sleep clinic to implement sleep diagnostic testing within their institution. Our end-to-end solution has the potential to improve the sleep and ultimately overall health of millions of patients,” de Francisco says.
Jed Black, MD, senior fellow, neuroscience at Onera investor Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine, says in a release, “Sleep disorders, such as narcolepsy or idiopathic hypersomnia, are frequently life-long conditions that can impact every facet of an individual’s life. Onera Health’s hardware and software innovations, as well as its streamlined service model, have the potential to create an important opportunity for clinicians to have a new testing and diagnostic tool for their patients to receive a quicker diagnosis and ultimately lead to optimal sleep care.”
The company stated 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 in June.