New Clinical Study Publication Validates Respiratory Outcomes for the Onera Home-polysomnography System

EINDHOVEN, Netherlands--(BUSINESS WIRE)--Jan 12, 2026--

Onera Health, a leader in transforming sleep medicine, announces the recent publication of a multicenter validation study of its Onera Sleep Test System (STS) in the ERJ Open Research, a leading, fully open-access scientific journal published by the European Respiratory Society (ERS). This is the second publication from this study, and it demonstrates that the patch-based Onera STS home-polysomnography (hPSG) device accurately identifies respiratory events and distinguishes AHI severity when validated against simultaneous in-lab polysomnography and is a viable option for unattended home use.

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The international multicenter study was managed by an independent Clinical Research Organization and involved the analysis of 206 participants across seven clinical sites in Germany and a US-based core laboratory at Johns Hopkins University. As detailed in the first publication, the study found high concordance between the Onera STS and traditional PSG across essential sleep variables and key respiratory parameters, as well as substantial epoch-by-epoch agreement in sleep staging and comparable inter-scorer reliability between the two systems, which is essential for physicians to make accurate diagnoses and treatment decisions in sleep medicine. This publication extends those findings to include accurately identifying respiratory events and distinguishing AHI severity when validated against simultaneous in-lab polysomnography, further validating the Onera STS as a viable option for unattended home use.

" We are very pleased to have further validation of the utility of Onera STS in accurately identifying respiratory events and distinguishing AHI severity,” said Ruben de Francisco, Founder and CEO of Onera Health. " This comprehensive validation study further demonstrates that our innovative, patch-based technology can deliver the level of accuracy needed for a comprehensive hPSG sleep test, with an accuracy that is equivalent to that of traditional in-lab PSG for all relevant clinical parameters. This publication further supports our mission to make the gold-standard sleep test, polysomnography or PSG, available at the patient’s home.”

" These additional results from the Onera STS validation study further demonstrate the diagnostic value of high-quality sleep assessment in the patient's natural environment. The ability to achieve results from home PSG testing that are equivalent to in-lab PSG will help remove the barriers to access created by resource limitations thus providing accurate diagnosis to significantly more patients suffering from under or undiagnosed sleep disorders,” added Dr. David P. White, Harvard Medical School, Boston, United States, and Member of the Medical Advisory Board at Onera Health.

This landmark validation study is part of Onera Health's comprehensive clinical evidence generation program, demonstrating the commitment to rigorous scientific validation of Onera’s technology. Additional studies are currently ongoing across multiple centers and healthcare settings, which will further validate the clinical utility and real-world impact of Onera’s home Polysomnography solution. This evidence generation strategy reflects Onera’s dedication to advancing sleep medicine through high-quality clinical research.

This study publication, entitled 'Clinical validation of respiratory outcomes for a patch-based polysomnography system', is published in the ERJ Open Research journal published by the European Respiratory Society (ERS) and can be accessed online at https://publications.ersnet.org/content/erjor/early/2025/12/04/2312054100857-2025https://doi.org/10.1183/23120541.00857-2025.

The first publication from this study entitled 'Clinical validation of a wireless patch-based polysomnography system', was published in the Journal of Clinical Sleep Medicine and can be accessed online at https://doi.org/10.5664/jcsm.11524

About Onera

Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments while also impacting other medical fields by monitoring various chronic conditions, ultimately improving the health and quality of life of patients worldwide. The company’s innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs. Onera has offices in the Netherlands and the U.S. For more information, go to onerahealth.com

Patient sleeps with the patient-applied Onera home Polysomnography (Onera hPSG) solution.

MUNICH--(BUSINESS WIRE)--Mar 20, 2026--

Dr. James Yu, Chairman and CEO of autonomous vehicle technology leader QCraft, engaged in an in-depth discussion with industry experts at the Intelligent Vehicles & Production 2026 conference on March 18, contending that autonomous driving is the most commercially viable pathway to physical AI—the emerging class of intelligence that understands and operates in the real world.

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The two-day conference, held in Garching bei München and jointly organized by the Center Automotive Research (CAR) and Technische Universität München (TUM), drew senior leaders from Mercedes-Benz, Audi, Bosch, Siemens, Rheinmetall, and other major industry players for a series of discussions on the future of intelligent vehicles, autonomous driving, and production innovation.

Dr. Yu's presentation, titled "Beyond Autonomous Driving: Physical AI in the Real World," was followed by a detailed exchange with Professor Ferdinand Dudenhöffer, founder of the Center Automotive Research in Bochum, Germany, and host of the forum. The conversation touched on the challenges and opportunities of bringing physical AI from theory to production at global scale.

During the session, which also featured Nico Michels of Siemens, Dr. Christian Steinborn of Rheinmetall, and Prof. Alois Knoll of TUM, Dr. Yu traced the arc of autonomous driving through three distinct stages. The first, he explained, relied on modular machine intelligence, where perception, prediction, and planning operated independently. The second saw the rise of human-like end-to-end learning, with AI trained on massive datasets to mimic human driving behavior. Now, in 2026, Dr. Yu maintained the industry is entering a third and defining phase: superhuman intelligence, driven by VLA large models, world models, and reinforcement learning. This is where AI no longer imitates humans but begins to truly understand the physical world.

"In the digital world, AI has already approached the level of general intelligence, and may even be entering the era of superintelligence. But the next great breakthrough will come from the physical world. When AI begins to understand gravity, friction, and human intention, that is where the biggest impact will be felt,” said Dr. Yu.

As an example of how this vision is becoming a reality, Dr. Yu pointed to a major milestone QCraft reached: more than one million vehicles now operate with the company's Navigate on Autopilot system. He described each of those vehicles as a robot on four wheels, collecting real-world data from complex and unpredictable driving scenarios every day. Taken together, he emphasized, this growing fleet forms an unmatched training ground for physical AI.

A central topic in the discussion was the core challenge facing autonomous driving: testing in the physical world is inherently costly and time-consuming. Because autonomous driving must be thoroughly validated across an enormous range of scenarios to ensure safety, Dr. Yu underscored, achieving that bar is exceptionally difficult. That is why QCraft has built what Dr. Yu likened to a virtual driving school, where world models simulate millions of these safety-critical scenarios and reinforcement learning allows the AI to test, fail, and optimize its decisions, all before the vehicle hits the road.

QCraft chose Munich for its European headquarters, which opened in September 2025. That was no coincidence, Dr. Yu said. Munich sits at the crossroads of two worlds QCraft wants to bridge: the fast-moving AI ecosystem forged on China's dense, unpredictable roads, and Germany's century-long tradition of automotive engineering excellence. The company is now actively building a team there, recruiting top talent to support its global expansion.

Dr. Yu closed with a broader ambition. What QCraft is building, he said, is not simply a smarter car. It is a physical intelligence platform. Today it drives passenger cars. Tomorrow, he suggested, the same underlying intelligence could power robots and any machine that must perceive, reason, and act in the physical world. The autonomous vehicle, in his telling, is just the first chapter.

About QCraft

QCraft is a global leader in L2++ to L4 autonomous driving (AD) solutions for automakers. Founded in Silicon Valley in 2019, the company has deployed its technology in more than 1 million vehicles. Powered by a world-class R&D team and partnerships with leading OEMs and tech companies, QCraft combines proven large-scale adoption with industry-leading safety and efficiency to bring autonomous driving into real life.

Dr. James Yu of QCraft and Prof. Dr. Ferdinand Dudenhöffer, the founder of the Center Automotive Research (CAR)