NetworkNewsBreaks – Vivos Therapeutics Inc. (NAS
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Posted On: 03/10/2021 4:59:10 PM
NetworkNewsBreaks – Vivos Therapeutics Inc. (NASDAQ: VVOS) Announces FDA 510(k) Application for Exclusive Oral Appliance
Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing including obstructive sleep apnea (“OSA”), recently submitted an application to the U.S. Food and Drug Administration (“FDA”) for its mmRNA (“mmRNA”) oral appliance(TM). The 510(k) Class II application focuses on the oral appliance as a treatment for mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. The company’s oral appliance is an updated version of the company’s existing mRNA appliance(R), which previously received FDA clearance as a Class II oral appliance. The company noted that once it received approval for the 510(k) application, it plans to submit an application to a pricing, data analysis and coding (“PDAC”) contractor for the appliance to be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances. The process could take anywhere from three to six months. “Following mechanical testing on the mmRNA, this 510(k) submission marks a significant step toward Vivos continuing to offer a state-of-the-art treatment alternative for people suffering from mild-to-moderate OSA,” said Vivos chairman and CEO Kirk Huntsman in the press release. “Furthermore, FDA clearance for the mmRNA will enable us to expand insurance reimbursement to include Medicare. Sleep apnea remains a serious, chronic disease that adversely impacts millions of people, and Vivos is steadfast in its mission to reach as many patients as possible around the country with our next-generation products.”
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 treatments for patients suffering from sleep-disordered breathing including obstructive sleep apnea (“OSA”), recently submitted an application to the U.S. Food and Drug Administration (“FDA”) for its mmRNA (“mmRNA”) oral appliance(TM). The 510(k) Class II application focuses on the oral appliance as a treatment for mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. The company’s oral appliance is an updated version of the company’s existing mRNA appliance(R), which previously received FDA clearance as a Class II oral appliance. The company noted that once it received approval for the 510(k) application, it plans to submit an application to a pricing, data analysis and coding (“PDAC”) contractor for the appliance to be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances. The process could take anywhere from three to six months. “Following mechanical testing on the mmRNA, this 510(k) submission marks a significant step toward Vivos continuing to offer a state-of-the-art treatment alternative for people suffering from mild-to-moderate OSA,” said Vivos chairman and CEO Kirk Huntsman in the press release. “Furthermore, FDA clearance for the mmRNA will enable us to expand insurance reimbursement to include Medicare. Sleep apnea remains a serious, chronic disease that adversely impacts millions of people, and Vivos is steadfast in its mission to reach as many patients as possible around the country with our next-generation products.”
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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