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 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Onera’s clinical-grade technology is a huge step forward in transforming the outdated, cumbersome, and expensive process of traditional sleep testing, which is partly responsible for the underdiagnosis of sleep disorders.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.
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.
P: +31 (0)40 3082177
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
Deenova Keeps Up its Competitive Streak in France with 2 New Tender Awards at Hazebrouck and Mantes-La-Jolie17.5.2022 06:00:00 CEST | Press release
Deenova today announced that it continued its last 2 years market dominance in France with another net new RESAH competitive award for its D3 ACCED mechatronic solutions at Centre Hospitalier Hazebrouck near Dunkerque. Separately, Deenova is pleased to simultaneously announce add-on sales of 4 ASTUS cabinets to existing Deenova customer Centre Hospitalier François Quesnay de Mantes-La-Jolie. Loïc Bessin, Managing Director of Deenova in France stated: “Combining net new business awards at premier hospital groups like RESAH with Centre Hospitalier Hazebrouck, while at the same time earning the trust of additional add-on sales by previous Deenova customers such as Centre Hospitalier François Quesnay de Mantes-La-Jolie is self-evident proof of Deenova France maturity, showing a high level of continued satisfaction with our automation solutions amongst our existing customer base in France.” Christophe Jaffuel, Deenova Chief Commercial Officer, added: “I am extremely pleased to continue to w
Import Prohibition in Europe as Result of Search and Seizure by French Court17.5.2022 02:00:00 CEST | Press release
Seoul Viosys (“SVC”) (KOSDAQ: 092190), a subsidiary of Seoul Semiconductor Co., Ltd., has won a patent litigation against a European home appliance distributor that infringed its Violeds technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220516005048/en/ Violeds technology applied to air purification solutions (Graphic: Business Wire) In February 2022, Seoul Viosys filed patent litigation against FTHMM International B.V., a Netherlands trading company, in The Hague District Court of the Netherlands, seeking a preliminary injunction against the sales of infringing UV LED products. The asserted patent relates to Violeds technology that can effectively disinfect water, air space, and surfaces by using ultraviolet lights. According to the cease and desist declaration approved by the court, FTHMM acknowledged infringing Seoul Viosys’ patent and will be required to cease all sales of infringing UV LED products and destroy
Conviva Announces Streaming Audience Measurement Standard Leveraging Comprehensive, Continuous, Census-level Technology16.5.2022 20:21:00 CEST | Press release
Conviva, the Continuous Measurement Analytics platform for streaming media, today announces it will unveil a streaming audience measurement standard to be released for general availability at CES 2023. This expansion is in partnership with premium streaming providers using Conviva’s real-time cloud sessionization technology. The new standard provides census-level streaming audience ad packaging and measurement that is complimentary and interoperable with linear TV allowing streaming providers to compete at scale with the digital walled gardens solutions competing for ad budgets today. Conviva’s platform currently processes nearly 3 trillion streaming data events daily, supporting more than 500 million unique viewers watching 200 billion streams per year across 4 billion applications streaming on devices. “Audience measurement represents the streaming industry’s biggest opportunity and Conviva’s technology definitively unlocks its potential,” comments Keith Zubchevich, CEO of Conviva. “
Verimatrix Anti-Piracy and Threat Defense Experts To Highlight Latest Innovations at CABSAT and TT CS16.5.2022 17:45:00 CEST | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced participation in two leading conferences this month: European Medical Device and Diagnostic Software Development and Compliance Conference (TT CS) – May 17-18 – Brussels, Belgium TT CS is Europe’s only dedicated conference for medtech cybersecurity professionals. Held at the Sheraton Brussels Airport Hotel, the event features two Verimatrix speakers. Nicole Lua, sales director, is scheduled to serve as moderator for a “Security By Design” roundtable at 1:35 p.m. on May 17. Neal Michie, director of product management, is scheduled to discuss the prevention of threats associated with unmanaged and quasi-managed devices during a session slated for 10:15-10:50 a.m. on May 18. CABSAT – May 17-19 – Dubai, UAE CABSAT is the most established and respected trade platform for broadcast, satellite, entertainment content & digital media sectors across
“Our Future is Light” Campaign Kicks off 2022 International Day of Light16.5.2022 17:03:00 CEST | Press release
An action-packed video styled as a blockbuster-movie trailer provides the linchpin for this year’s International Day of Light (IDL) campaign, “Our future is light. Play your part.” Released today, Day of Light features diverse characters successfully solving global-level problems using photonics-enabled technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220516005150/en/ Sponsored by SPIE, Optica, and IEEE Photonics Society, this year’s International Day of Light celebration showcases exciting, critical career opportunities in optics and photonics. (Graphic: Business Wire) Three professional societies – SPIE, the international society for optics and photonics, IEEE Photonics Society, and Optica, Advancing Optics & Photonics Worldwide – partnered to create the video and the accompanying 2022 IDL campaign. “Our future is light. Play your part” promotes the importance of light-based technologies and interesting careers
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