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According to the current American Academy of Sleep Medicine treatment guidelines, [1] oral appliances should be considered for patients with snoring or minor to moderate sleep apnea, or as an alternative to CPAP in non compliant patients with severe obstructive sleep apnea. Where appropriate, they are considered a good therapy choice as they ...
Oral pressure therapy (OPT) is a treatment for obstructive sleep apnea (OSA) that uses negative pressure in the mouth to shift the soft palate and tongue forward. [1] The negative pressure is created by a bedside console connected by a small tube to a mouthpiece worn inside the mouth during sleep.
Certain patients with obstructive sleep apnea who are deemed eligible candidates may be offered the hypoglossal nerve stimulator as an alternative. FDA-approved hypoglossal nerve neurostimulation is considered medically reasonable and necessary for the treatment of moderate to severe obstructive sleep apnea when all of the following criteria are met: [4]
The AIO Breathe Device is a “new mandibular repositioning device” that was designed by local sleep physician Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, […] FDA clears Tyler company’s device ...
Shares of the medical device maker more than doubled to $9.12 in premarket trading. The clearance is the first ever for an oral appliance, along with a mode of respiratory ventilation or exercise ...
South Dakota Gov. Kristi Noem was sued in Washington, D.C., on Wednesday over her promotion of a Texas dentist on her social media accounts this week. The lawsuit, filed by the consumer advocacy ...
A mouthguard is most often used to prevent injury in contact sports, as a treatment for bruxism or TMD, or as part of certain dental procedures, such as tooth bleaching or sleep apnea treatment. Depending on the application, it may also be called a mouth protector , mouth piece , gumshield , gumguard , nightguard , occlusal splint , bite splint ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...