Sleep Apnoea News
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Veravas Featured in the Minneapolis/St. Paul Business Journal
On June 27, Alex Wittenberg at the Minneapolis/St. Paul Business Journal published a profile of Veravas, highlighting both its long-term potential in the billion-dollar IVD market and the upcoming launch of its first suite of products. “Veravas Inc., founded last year, says it's developed a novel technology with the potential to change the way conditions such as Alzheimer's and sleep apnea ...
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AcuPebble SA100 offers automated sleep apnea diagnosis equivalent to cardiorespiratory polygraphy
AcuPebble SA100 is clinically equivalent to cardiorespiratory polygraphy for the automated diagnosis of obstructive sleep apnea (OSA) at home, a paper published in the BMJ Open has revealed. A powered clinical trial conducted by the Royal Free Hospital in London demonstrated both the accuracy and usability of the small device, which has the potential to open more efficient patient pathways for ...
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Acurable receives US FDA clearance for its home sleep apnoea testing device AcuPebble SA100
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, which received a CE Mark as a Class IIa medical device in 2020, was developed and is commercialised by UK-based medical device company Acurable and builds on more than ten ...
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Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S. Food and Drug Administration (FDA) has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device ...
By Nyxoah SA
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Inspire Medical Systems, Inc. Announces FDA Approval and Commercial Launch of New Physician Programmer Platform
Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, today announced receipt of U.S. Food and Drug Administration (“FDA”) approval for the new Inspire physician programmer platform. The most significant ...
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AcuPebble SA100 joins the NHS Innovation Accelerator 2021
AcuPebble SA100, the first medical device to obtain the CE mark for the automated diagnosis of Obstructive Sleep Apnoea, has been announced as one of 12 exciting innovations to join the NHS Innovation Accelerator 2021. This award-winning programme identifies early-stage solutions which address the most pressing needs of the NHS, and supports them over three years as they scale across England for ...
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Acurable launches groundbreaking technology to diagnose sleep apnoea remotely
Acurable, a fast-growing medical device company, has announced the availability of its first product, AcuPebble SA100, a small wearable device which for the first time enables a fully automated and remote diagnosis of obstructive sleep apnoea (OSA). Traditionally, the diagnosis of OSA has required multiple hospital visits for patients, and doctors have had to manually review and analyse data from ...
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Sommetrics Completes Study of New Sleep Apnea Treatment in Ethnic Japanese Subjects
VISTA, Calif. — JUNE 25, 2019 — Sommetrics a company dedicated to developing state of the art products to treat obstructive sleep apnea (OSA), today announced the completion of clinical study SOM-014. This trial evaluated the safety, tolerability and effectiveness of the Sommetrics aerSleep™ product in ethnic Japanese subjects with obstructive sleep apnea (OSA). This was a ...
By Sommetrics
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Renowned Sleep Expert Dr. Jerrold Kram to Present New Sleep Apnea Treatment by Sommetrics at SLEEP 2018
SAN DIEGO, Calif. — May 30, 2018 — Sommetrics, a company providing products and services to improve sleep quality, today announced that renowned sleep expert Jerrold Kram, M.D., FCCP, FAASM, will be discussing the company’s new sleep apnea treatment, aerSleepTM, during SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies in Baltimore, Maryland. ...
By Sommetrics
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