Eindhoven – August 5, 2026 — Onera Health, a leader in transforming sleep medicine, announces that its quality management system has been certified to meet the requirements of MDR (EU) 2017/745 regulation (Annex IX, chapter I and III). The Onera STS 2 system, which will be marketed as the Onera hPSG® solution, falls within the scope of the EU MDR certificate. This certification ensures continued access to the next generation of Onera sleep testing products for patients in Europe.
“This certification is the culmination of many hours of work from our very dedicated team. I greatly appreciate the efforts from the Onera team and the partnership with MDR inspectors and auditors that came together to make this achievement possible,” states Ruben de Francisco, Founder and CEO of Onera Health. “This certification will enable many patients throughout Europe to benefit from polysomnography testing in their home.”
About Onera Health
Onera Health is leading the way in transforming sleep medicine by delivering the gold standard of sleep testing, polysomnography (PSG), directly to where the patient sleeps comfortably, in their own home.
The Onera hPSG® solution is expanding access to comprehensive sleep diagnostics for millions of people who remain undiagnosed or undertreated by breaking down long-standing barriers such as limited lab capacity, geographic access, and operational complexity. Through its integrated diagnostic technology, clinical services, and digital platform, Onera hPSG® empowers clinicians with comprehensive, actionable insights while helping healthcare systems deliver more efficient, scalable care.
With commercial operations in the United States and Europe, Onera Health is at the forefront of advancing global sleep health and transforming how sleep disorders are detected, identified, and managed. For more information, visit onerahealth.com.
For additional information or media inquiries, please contact:
Swea Ann Hagenhoff
Sr. Branding and Communications Specialist
Onera Health
media@onerahealth.com
