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Vivos Therapeutics

All articles tagged with #vivos therapeutics

health2 years ago

FDA Clears Vivos Therapeutics' Breakthrough Sleep Apnea Treatment

Vivos Therapeutics has achieved a significant milestone with its first-ever 510(k) clearance from the FDA for the treatment of severe obstructive sleep apnea (OSA) in adults using its removable CARE oral appliances. This clearance allows Vivos to offer an alternative treatment option to patients with severe OSA, providing an alternative to CPAP therapy or surgical neurostimulation implants. It is the first time the FDA has granted approval for an oral appliance to treat both moderate and severe OSA in adults aged 18 and older. Vivos Therapeutics aims to improve the quality of life for individuals suffering from sleep apnea by providing effective and accessible treatment options.

via Yahoo Finance|
#alternative-treatment#fda-clearance#health
health2 years ago

FDA Clears Vivos Therapeutics' Oral Device for Sleep Apnea Treatment

Vivos Therapeutics has received clearance from the US FDA for its oral device designed to treat severe obstructive sleep apnea (OSA). This marks the first-ever clearance for an oral appliance to treat moderate and severe OSA in adults. The device gradually repositions the airway's hard and soft tissues, optimizing its function and flow. Study data supported the FDA's decision, showing a 50% improvement in the index used to determine the presence and severity of the disease. Shares of Vivos Therapeutics more than doubled in premarket trading following the announcement.

via Yahoo Finance|
#fda-clearance#health#medical-device
health2 years ago

FDA Grants First-Ever Clearance for Vivos Therapeutics' Oral Device to Treat Severe Sleep Apnea

Vivos Therapeutics has received FDA 510(k) clearance for its oral appliances, becoming the first company to offer an alternative treatment for severe obstructive sleep apnea (OSA) in adults. The clearance allows Vivos to market its removable CARE oral appliances as a clear alternative to CPAP or surgical neurostimulation implants for patients with severe OSA. The FDA clearance also marks the first time an oral appliance has been approved to treat moderate and severe OSA in adults. The statistically significant data submitted to the FDA showed that 80% of severe OSA patients experienced an improvement in their condition, with an average treatment time of just 9.7 months. Vivos' proprietary CARE appliances gradually reposition the hard and soft tissues of the airway, optimizing its function and flow.

via GlobeNewswire|
#alternative-to-cpap#fda-clearance#health