ApneaRx gets FDA nod for sleep apnea

The U.S. Food and Drug Administration (FDA) has approved the ApneaRx device from Apnea Sciences as a first line of treatment for less severe and noncompliant continuous positive airway pressure (CPAP) patients.

ApneaRx is the first thermal oral appliance that meets the new Medicare product standards of being adjustable by the patient in 1-mm increments, the company noted in a press release. ApneaRx does this without any moving parts, screws, metal rods, or plastic bands used by other sleep apnea devices or metal hardware that could compromise the patient.

Similar to custom oral appliances, the ApneaRx can be adjusted to help determine the clinical efficacy of oral appliances. If the ApneaRx treatment is successful, a more customized oral appliance can be prescribed. If not, CPAP should be used, according to the company.

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