Netherlands-based Onera BV has received a CE (Certificate of Conformity) for its patch-based home sleep testing system. The CE mark allows the device to be sold in the European market.
Different configurations of Onera’s device offer comprehensive data to support the diagnosis of various sleep disorders and enable clinicians to remotely monitor and optimize patients’ treatment. The user-centric technology enables 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, according to Onera.
“By obtaining the CE mark, Onera has achieved a critical regulatory milestone which is an important step toward delivering on our promise to make sleep testing more convenient, easy-to-use, and accessible to everyone, anywhere—even in the patient’s home,” says Ruben de Francisco, founder, chief technology officer, and interim CEO of Onera, in a release. “We are now in a position to introduce Onera’s technology in various configurations to the European market, working closely with doctors from different areas in medicine, beginning with exclusive partnerships in The Netherlands, Germany, and Italy while we continue to explore other geographies. Simultaneously are we awaiting the pending FDA approval for authorization in the US.”
Hartmut Schneider, MD, PhD, founder & chief medical officer of Onera, says in a release, “We are eager to offer physicians an innovation that extends their diagnostic repertoire in their day-to-day operations. Being able to order and obtain results of a sleep study, as easily as ordering blood work or a CT, will improve the care of all patients, whether they are in the hospital or at home.”
Onera is currently awaiting 510(k) clearance from the US Food and Drug Administration for its system. During the upcoming months, Onera will focus on strategic partnerships with exclusive European and American partners to evaluate the potential of the product and patch-based technology.