ONERA-HEALTH
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Onera’s clinical-grade technology is a huge step forward in transforming the outdated, cumbersome, and expensive process of traditional sleep testing, which is partly responsible for the underdiagnosis of sleep disorders.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
Civil Air Patrol Expands Fleet With 15 New Cessna Aircraft to Support Lifesaving and Community Missions15.12.2025 17:00:00 CET | Press release
Latest deliveries bring CAP’s Cessna fleet to more than 500 aircraft nationwide Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, announced today that Civil Air Patrol (CAP), the world’s largest operator of Cessna aircraft, is strengthening its national mission capabilities with an order for 15 additional piston-engine aircraft, including seven Cessna Skyhawk 172 and eight Cessna Skylane 182 models scheduled for delivery throughout 2026. The order follows recent deliveries of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft, expanding CAP’s fleet to more than 500 Cessna aircraft nationwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215613573/en/ Delivery of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft joins CAP’s fleet of more than 500 Cessna aircraft nationwide. Cessna aircraft are designed and produced by Textron Aviation. “Civil Air Patrol’s miss
Winston & Strawn and Taylor Wessing UK to Combine, Creating a Premier Transatlantic Law Firm15.12.2025 16:52:00 CET | Press release
Winston Taylor to build on shared vision and culture in establishing a transatlantic powerhouse for major litigation, critical transactions, strategic IP, and private wealth Winston & Strawn and Taylor Wessing’s UK-led business announced today their intention to combine, creating a premier transatlantic law firm that would operate under a new shared name, Winston Taylor. The combination responds to increasing client demand for seamlessly integrated US–UK–EU counsel for the businesses, people, and markets driving capital and innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215914957/en/ The combination once final will unite two international firms with more than 400 years of combined history, complementary strengths, and a common vision to meet clients’ evolving global needs. The combined firm will include more than 1,400 lawyers, establishing one of the largest transatlantic firms whose footprint is primarily in
Despite Barriers, Financial Institutions are Clear About AI's Greatest Impact15.12.2025 16:32:00 CET | Press release
HTEC Finds AI is Everywhere in FSI, but Scaling Across the Enterprise Remains the Industry's Biggest Hurdle HTEC, a global AI-first provider of software and hardware design and engineering services, today released The State of AI in Financial Services & Insurance 2025, a first industry subset of its global research report in AI. This publication offers one of the clearest views to date into how financial institutions are adopting and scaling artificial intelligence. This industry-focused report analyzes insights from 250 C-suite leaders within financial services and insurance, drawn from HTEC’s broader global study of 1,529 C-suite executives—including CIOs, CTOs, CDOs, CPOs, CFOs, COOs, CEOs and CSOs—across Saudi Arabia, the UAE, the United Kingdom, the United States, Germany and Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215790717/en/ Executive Summary: The State of AI in Financial Services and Insurance 2025
Align Partners Sends Second Public Shareholder Letter to Coway, Urging Announcement of Revised Value-up Plan by January 30, 202615.12.2025 15:54:00 CET | Press release
Align identifies an inefficient capital structure and a sharp contraction in shareholder returns as core drivers of Coway’s undervaluationThe letter outlines seven key measures to strengthen capital allocation and governanceAlign urges Coway to announce a more concrete and enhanced Value-up Plan by January 30, 2026 Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Coway Co., Ltd. (“Coway”) since 2023 holding more than 4% of the Company’s outstanding shares through funds it manages or advises, announced that it has sent a second public shareholder letter to Coway’s Board of Directors. The letter calls for measures to address the company’s chronic undervaluation and enhance shareholder value. Align Partners has requested that Coway announce a revised corporate Value-up Plan reflecting these proposals by January 30, 2026. In the letter, Align Partners assessed Coway’s February 2025 plan as insufficient to address Coway’s persistent undervaluation and urged the Bo
Marathon Asset Management Provides Junior Capital Financing to EXALTA Group15.12.2025 15:00:00 CET | Press release
Marathon Asset Management (“Marathon”), a leading global credit manager with more than $24 billion of assets under management, is pleased to announce the closing of a junior capital financing to EXALTA Group (“EXALTA” or the “Company”), a portfolio company of Montagu. Marathon led the financing that supported the formation of EXALTA through the strategic merger of three Montagu-owned companies including Intech, Resolve Surgical Technologies, and Tyber Medical. The transaction marks one of many successful transactions for Marathon’s European Credit business in the healthcare sector, where the firm has a knowledge-based advantage with a dedicated Healthcare Finance business and specialized medical advisory board providing sector insight to middle market companies. EXALTA is a global leader in orthopaedic contract design and manufacturing for spine, trauma, extremities, sports medicine and enabling technology providing comprehensive solutions to OEMs within the medical technology industry
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