FDA Grants 510(k) Clearance to Onera STS, a System for At-Home and In-Lab Polysomnography Studies
28.4.2022 16:19:00 EEST | 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 has received 510(k) clearance from the US Food and Drug Administration (FDA) for its innovative patch-based system for sleep studies, Onera STS (Photo: Business Wire)
Onera’s clinical-grade technology is a huge step forward in transforming the outdated, cumbersome, and expensive process of traditional sleep testing, which is partly responsible for the underdiagnosis of sleep disorders.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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220428005750/en/
Contact information
Swea Hagenhoff
P: +31 (0)40 3082177
E: media@onerahealth.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
LabGenius Therapeutics and LG Chem Enter a Research Collaboration, Option and License Agreement to Develop an AI/ML-Designed Tumour-Targeting Antibody18.6.2026 02:01:00 EEST | Press release
LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise therapeutic antibodies, today announced a multi-year research collaboration, option and licensing agreement with LG Chem. The collaboration aims to identify next-generation multispecific antibodies designed to overcome the key limitations of existing immunotherapies, including on-target, off-tumour toxicities. Together, the companies will aim to develop a novel, tumour-selective therapeutic targeting a solid tumour antigen expressed across multiple difficult-to-treat cancer types. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615992992/en/ “Partnering with LG Chem represents a very important moment for LabGenius and provides further validation of our platform’s ability to design highly optimised multispecific antibodies,”said Dr. James Field, CEO of LabGenius. “We welcome this opp
Joe Vernachio Named President of SOREL18.6.2026 01:00:00 EEST | Press release
Columbia Sportswear Company (Nasdaq: COLM), a leading innovator in active outdoor apparel, footwear, accessories and equipment, today announced that Joe Vernachio will be the next President of SOREL. Founded in 1962, SOREL is a leader in functional and lifestyle footwear that can be worn anywhere from the tundra to the streets of New York City. “We’re excited to welcome Joe Vernachio back to the Columbia Sportswear family,” said Tim Boyle, CEO and Chair of the Board. “Joe is a terrific leader who can build on the great work, talent and momentum in place at SOREL.” Mr. Vernachio led the Mountain Hardwear brand for several years, until he left to become the COO and ultimately, the CEO of Allbirds. His background also includes time as Global Vice President for Product and Operations at The North Face, and key roles at Nike, Spyder, Roots, Calvin Klein and Patagonia. “Joe is a consumer‑focused, collaborative leader with a deep passion for product and brand storytelling. His energy, experti
Venture Global and EnBW Announce New LNG Purchase Agreements17.6.2026 23:30:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and EnBW announced the execution of new, binding agreements for the purchase of approximately 0.82 million tonnes per annum (MTPA) of U.S. liquefied natural gas (LNG) from Venture Global for approximately five years commencing in 2026, to be supplied from Venture Global’s portfolio. The new agreements add to the existing long-term sales and purchase agreements (SPAs) between Venture Global and EnBW for 2 MTPA for 20 years. “As one of Germany’s top LNG suppliers, Venture Global is proud to strengthen our partnership with EnBW and support the region’s energy security with a reliable supply of LNG,” said Venture Global CEO Mike Sabel. “The new mid-term agreements build on our strong, long-standing relationship with EnBW and reflects our commitment to meeting our customers’ evolving energy needs. Our dynamic marketing platform uniquely positions us to provide supply solutions across the short, medium, and long term.” About Venture Global Venture Globa
Kinaxis Announces Results of Voting at Annual and Special Meeting of Shareholders17.6.2026 23:05:00 EEST | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, received approval for all resolutions put forward to shareholders at today’s Annual and Special Meeting of Shareholders (the “Meeting”), as detailed in the Company’s management information circular dated May 5, 2026 (the “Circular”). 1. Election of Directors Shareholders voted to elect all eight directors nominated to the Kinaxis board, to hold office until the close of the next annual meeting of shareholders of the Company or until their successors are elected or appointed. Name of Nominee Total Number of Votes For Percentage of Votes For Total Number of Votes Against Percentage of Votes Against Razat Gaurav 21,870,163 99.01% 219,468 0.99% Robert Courteau 20,882,945 94.54% 1,206,685 5.46% Gillian (Jill) Denham 21,474,486 97.22% 615,143 2.78% José Alberto Duarte 21,699,181 98.23% 390,448 1.77% Lynn Loewen 21,952,244 99.38% 137,387 0.62% Angel Mendez 21,410,402 96
SES Announces Results of the Extraordinary General Meeting of Shareholders17.6.2026 20:23:00 EEST | Press release
SES (the “Company”) held an Extraordinary General Meeting (“EGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions. In particular, shareholders approved the cancellation of shares repurchased under the Company’s share buyback program of 2 November 2023, as amended on 2 May 2024, resulting in a corresponding reduction of the Company’s share capital. Shareholders also approved amendments to the Company’s articles of association, including indemnification for Board members and executives, as well as updates relating to the conduct of shareholder meetings. Detailed results on all matters voted on at the EGM will be available on the company’s webpage: https://www.ses.com/company/investors/shareholder-information/general-meeting-shareholders Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we b
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