ONERA-HEALTH
28.4.2022 15:21:08 CEST | Business Wire | Press release
Onera Health, a leader in transforming sleep medicine and remote monitoring, announced today that its wholly-owned subsidiary in the Netherlands, Onera B.V., has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) for its ground-breaking system for Polysomnography (PSG) studies, Onera STS, paving the way for widespread deployment of the patch-based technology across healthcare systems in the U.S. 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220428005750/en/
Onera’s clinical-grade technology is a huge step forward in transforming the outdated, cumbersome, and expensive process of traditional sleep testing, which is partly responsible for the underdiagnosis of sleep disorders.
“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. “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 and simplifies 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 ”, explains de Francisco.
“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 ”, says Jed Black, M.D., senior fellow, neuroscience at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine.
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, from 4th-8th June 2022 in Charlotte, NC.
About Onera
Onera Health is a leader in transforming diagnostics and monitoring. Their breakthrough products and technologies are poised to help millions of people struggling with health ailments and chronic conditions in a variety of medical fields, including sleep, neuro, cardiac and respiratory care, ultimately improving the health and quality of life for patients around the world. The company’s innovative solutions provide comprehensive physiological and health-related 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 US. For more information, go to www.onerahealth.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20220428005750/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations28.8.2026 11:00:00 CEST | Press release
Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely
MTG-I2 Safely in Orbit, Unlocking Faster and Sharper Weather Monitoring Across Europe28.8.2026 10:16:00 CEST | Press release
The Meteosat Third Generation Imager 2 satellite (MTG-I2) has successfully passed its first critical post-launch milestones, completing the first full Meteosat Third Generation constellation in orbit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828243790/en/ Credit: Arianespace livestream The imager satellite MTG-I2 is safely in orbit and operating as expected following its successful launch yesterday at 22:11 CEST on board an Ariane 6 rocket from Europe’s Spaceport in French Guiana. Our teams have established communication with the spacecraft, which has also deployed its solar panels to ensure its autonomous production of energy. MTG-I2 is in perfect shape to start its Launch and Early Operations Phase that will bring it to a higher orbit, 36 000km above Earth over the following two weeks, where a longer period of calibration and validation of its instruments will begin. This summer’s extreme weather and wildfires hav
New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk28.8.2026 10:00:00 CEST | Press release
Analyses from the multinational MILOS study show that LDL-C reductions achieved with up to one year of treatment with bempedoic acid-containing therapies translate to a 17.1% relative reduction and a 4.8% absolute reduction in predicted 10-year cardiovascular risk.1 Real-world data demonstrated clinically relevant mean LDL-C reductions of at least 24.9%, regardless of patient gender or glycaemic status, after one year of follow-up.2,3 Findings presented at ESC Congress 2026 reinforce the clinical value of bempedoic acid in routine clinical practice, and demonstrate the continued investment of Daiichi Sankyo in addressing outstanding unmet needs in cardiovascular disease (CVD). Daiichi Sankyo (TSE:4568) today announced new results from the MILOS study that demonstrate the real-world impact of bempedoic acid administered either alone or as a fixed-dose combination with ezetimibe, in the management of dyslipidaemia. Presented at the European Society of Cardiology Congress 2026 in Munich,
TVS Motor Company Appoints Peyman Kargar as Director and Chief Executive Officer28.8.2026 09:31:00 CEST | Press release
Peyman Kargar appointed Director and Chief Executive Officer of TVS Motor Company, effective January 27, 2027 K. N. Radhakrishnan to continue as Director and Chief Executive Officer until then and subsequently will serve as Non-Executive Director up to the date of the ensuing AGM scheduled in July 2027 Appointment supports TVS Motor Company's next phase of growth and innovation TVS Motor Company, part of TVS VENU and a leading global manufacturer of two and three-wheelers, today announced the appointment of Peyman Kargar as Director and Chief Executive Officer, effective January 27, 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827012301/en/ Peyman Kargar Peyman will succeed K. N. Radhakrishnan, who will continue in his role until then to ensure a seamless transition. Following the transition, Radhakrishnan will serve as Non-Executive Director up to the date of the ensuing AGM scheduled in July 2027. He has been a
Philips and Imricor Launch Cardiac Interventional MR Lab Solution, Expanding Longstanding Collaboration27.8.2026 21:27:00 CEST | Press release
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Imricor Medical Systems (ASX: IMR), a pioneer and world-leading developer of MR-compatible products for interventional MR procedures, today announced a new Interventional MR (iMR) lab solution for Philips 1.5T MR. The first commercially available configuration* combines Philips’ 1.5T MRI platform and Imricor's portfolio of iMR systems and consumables, enabling an MR-guided workflow for cardiac intervention, without compromising on MR field strength. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827693715/en/ Meeting the need for greater tissue insight during cardiac intervention Cardiac arrhythmias affect millions of people worldwide, and catheter ablation is an established and increasingly utilized treatment for many complex cardiac arrhythmias. Yet today, these procedures continue to rely primarily on X-ray fluoroscopy, which provides only
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom