NetworkNewsBreaks – Vivos Therapeutics Inc. (NAS
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Posted On: 08/23/2021 4:19:10 PM
NetworkNewsBreaks – Vivos Therapeutics Inc. (NASDAQ: VVOS) Receives FDA Clearance for mmRNA Oral Appliance
Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, including mild-to-moderate obstructive sleep apnea (“OSA”), has received 510(k) market clearance from the FDA for its modified mandibular repositioning nighttime appliance (“mmRNA”). The device is designed to treat mild-to-moderate OSA in adults; it is also used for treating sleep-disordered breathing and snoring. The FDA approval expands insurance reimbursement potential, including the potential for the device to be covered by Medicare. The FDA approval also opens the door for future government contracts and other commercial payers. According to the announcement, more than 1 billion people globally and 54 million Americans suffer from sleep apnea, so the potential market for the device is significant. “The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA, a debilitating condition that causes or contributes to a wide range of chronic health issues,” said Vivos chair and CEO Kirk Huntsman in the press release. “Next-generation products like the mmRNA are vital for allowing medical doctors and dentists to continue pushing forward in their joint mission to give patients a better alternative for effectively treating their OSA. Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, including mild-to-moderate obstructive sleep apnea (“OSA”), has received 510(k) market clearance from the FDA for its modified mandibular repositioning nighttime appliance (“mmRNA”). The device is designed to treat mild-to-moderate OSA in adults; it is also used for treating sleep-disordered breathing and snoring. The FDA approval expands insurance reimbursement potential, including the potential for the device to be covered by Medicare. The FDA approval also opens the door for future government contracts and other commercial payers. According to the announcement, more than 1 billion people globally and 54 million Americans suffer from sleep apnea, so the potential market for the device is significant. “The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA, a debilitating condition that causes or contributes to a wide range of chronic health issues,” said Vivos chair and CEO Kirk Huntsman in the press release. “Next-generation products like the mmRNA are vital for allowing medical doctors and dentists to continue pushing forward in their joint mission to give patients a better alternative for effectively treating their OSA. Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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