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ProSomnus adds new oral appliance to FDA-cleared EVO line

June 18, 2025
in Sleep Info
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ProSomnus has expanded its EVO line with a brand new oral equipment designed for obstructive sleep apnea. Known as EVO Guided, the corporate says it’s the first bioengineered oral gadget deliberately designed to dilate each the velopharynx and the oropharynx.

About EVO Guided

ProSomnus EVO Guided is engineered to information, stabilize and titrate the mandible right into a prescribed therapeutic place. Its anatomical splint design offers as much as 14 instances extra tongue area and guides the tongue into an anterior posture whereas aiding mouth closure. Customized-made from the affected person’s oral information, the gadget makes use of no prefabricated elements.

In accordance with the corporate, EVO Guided incorporates a 95-degree guided prescription mechanism that guides the mouth closed and stabilizes the mandible inside microns of the goal place after titration. The lingual-less overlays are designed to scale back deformation and collapse of the ventral wall of the velopharynx, serving to maintain the airway open with out limiting tongue motion.

ProSomnus launched EVO Guided within the U.S. in Could through the 2025 American Academy of Dental Sleep Drugs annual assembly in Las Vegas. The corporate initially obtained FDA clearance for the EVO line in 2020.

About oral equipment remedy

Oral equipment remedy is a non-invasive therapy for loud night breathing and sleep apnea, involving using a detachable gadget worn within the mouth throughout sleep. These home equipment, various in look, are favored by some sufferers for his or her ease of use and portability, as they’re smaller and extra travel-friendly in comparison with conventional CPAP machines, taking just a few weeks for most people to adapt to sleeping with them.

Learn extra trade information from the AASM.



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Tags: addsapplianceEVOFDAclearedLineoralProSomnus
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