Business Wire

ONERA-HEALTH

Share
FDA Grants 510(k) Clearance to Onera STS, a System for At-Home and In-Lab Polysomnography Studies

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Onera’s clinical-grade technology is a huge step forward in transforming the outdated, cumbersome, and expensive process of traditional sleep testing, which is partly responsible for the underdiagnosis of sleep disorders.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

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Vertex Announces Broad Reimbursement Agreement With NHS England for ALYFTREK® (Deutivacaftor/Tezacaftor/Vanzacaftor) an Innovative Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis15.7.2025 01:01:00 CEST | Press release

- All eligible people with CF in England can now benefit from this medicine - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has reached a broad reimbursement agreement with NHS England for Vertex’s cystic fibrosis (CF) medicine ALYFTREK® (deutivacaftor/tezacaftor/vanzacaftor). This agreement comes as the National Institute for Health and Care Excellence (NICE) has issued a positive final draft recommendation for this medicine. This next-in-class triple combination treatment is licensed for people living with CF aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. “We’re proud that ALYFTREK®, our fifth CF medicine, is available today as another treatment option for all eligible CF patients in England. It represents a significant milestone in our journey to serially innovate and further improve the lives of people living with this disease,” said Lud

SES Receives All Required Regulatory Approvals to Complete Intelsat Acquisition14.7.2025 22:15:00 CEST | Press release

SES received the final regulatory approvals for the SES-Intelsat transaction, including the US Federal Communications Commission. On 30 April 2024, SES and Intelsat announced an agreement for SES to acquire Intelsat for a cash consideration of $3.1 billion (€2.8 billion). The transaction was subject to receipt of relevant regulatory clearances and other relevant requirements which all have now been obtained. As a result, SES plans to close the transaction on or about Thursday, 17 July 2025. Once closing has occurred, a press release will be published to confirm that the transaction has successfully closed. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES SES has a bold vision to deliver amazing experiences everywhere on Earth by distributing the highest quality video content and providing seamless data connectivity services around the world. As a provider of global content and connectivity solutions, SES owns and ope

Loomis Sayles Celebrates 15 Years of Growth Equity Strategies Team Under Leadership of Aziz V. Hamzaogullari14.7.2025 22:05:00 CEST | Press release

Loomis, Sayles & Company: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714614048/en/ 90.7 160 1 BILLION IN ASSETS UNDER MANAGEMENT COMBINED YEARS OF INVESTMENT EXPERIENCE INVESTMENT PHILOSOPHY GES Team As of 5/31/2025 GES Team As of 5/31/2025 Supported by a seven-step research framework Loomis, Sayles & Company proudly celebrates the 15-year anniversary of a differentiated approach to growth equity investing under the leadership of Aziz V. Hamzaogullari, CFA, the founder, chief investment officer and portfolio manager of the Loomis Sayles Growth Equity Strategies (GES) Team. Aziz is also an executive vice president and a member of the firm’s Board of Directors. GES is a cohesive team with nearly 19 years of alpha generation and a long-term, private equity approach to investing. Under Aziz Hamzaogullari’s leadership since 2010, assets under management for GES have grown from $1.9 billion to nearly $91 billion as of 31 Ma

Cessna Skyhawk Soars With Enhanced Efficiency: Solid-State Dual Electronic Ignition System Introduced to the Industry-leading Piston14.7.2025 18:00:00 CEST | Press release

The industry-leading training aircraft, the Cessna Skyhawk, now features a dual electronic ignition system (dual EIS), enhancing maintenance, efficiency and overall operation of the single-engine, high-wing piston. The dual Lycoming electronic ignition system is now standard on all new Cessna Skyhawk aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714759359/en/ Cessna Skyhawk soars with enhanced efficiency: solid-state dual electronic ignition system introduced to the industry-leading piston (Photo Credit: Textron Aviation) The Cessna Skyhawk is designed and produced by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. The dual EIS replaces the previous dual magneto ignition system on the Skyhawk, incorporating advanced electronic components and reducing the number of internal moving parts to optimize operation. This solid-state electronic technology improves maintenance intervals, fuel efficiency and en

The 2025 Empire State Building Run-Up Returns Oct. 814.7.2025 17:48:00 CEST | Press release

Presented by NYU Langone Health and Powered by the Challenged Athletes FoundationLottery Opens July 14 The Empire State Building (ESB) announced today general lottery registration for the annual Empire State Building Run-Up (ESBRU) on Oct. 8, 2025, at 8 p.m. ESB also announced the ESBRU will be presented by NYU Langone Health and powered by the Challenged Athlete’s Foundation. General lottery registration will be open from July 14 through July 28, 2025. In the 47th annual Run-Up, 225 runners will race up the iconic building’s 1,576 stairs to the world-famous Observatory. This year’s heats will include elite men and women, media, celebrities, New York City real estate brokers, building tenants, CAF athletes, members of the NYPD and FDNY, and the public, among others. On July 30, registered runners will be notified of their race status with participation costs of $175 per runner to be charged only upon acceptance from the lottery. “We are delighted to welcome NYU Langone Health as our ne

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye