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Thursday, October 23, 2025

3D printed sleep apnea machine receives FDA clearance


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Airway Administration, a developer of superior oral home equipment, has achieved FDA clearance for its Nylon flexTAP, one of many first digitally printed single-point midline oral equipment units for sleep apnea. The machine redefines affected person care by combining patented Vertex Expertise with unparalleled consolation and efficacy, now FDA-cleared for delicate to average obstructive sleep apnea (OSA).

Airway Management's 3D printed Nylon flexTAP receives FDA clearance for mild to moderate obstructive sleep apnea.Key options and advantages embody: digitally printed medical-grade Nylon; patented Vertex Expertise; 17mm vary of development; ultra-thin customized TAP trays; BPA-free and metal-free; no chew registration required; Mouth Protect and AM Aligner included; and a 4-year guarantee.

“We’re thrilled to introduce the Nylon flexTAP, a game-changer in oral equipment remedy,” stated Charles Collins, CEO of Airway Administration. “Suggestions from key opinion leaders in our TAP Sleep Care system highlights its superior effectiveness and affected person consolation. Peer-reviewed research additionally affirm that our patented mouth protect, which promotes nasal respiration, considerably improves therapy outcomes. This innovation underscores our dedication to advancing sleep well being.”

Since 2015, the American Academy of Sleep Medication (AASM) and American Academy of Dental Sleep Medication (AADSM) have advisable oral equipment remedy for delicate to average sleep apnea. The Nylon flexTAP units a brand new benchmark by leveraging digital printing know-how, eliminating the necessity for chew registration whereas sustaining precision.

Manufactured within the USA, the machine is now out there by Airway Labs, with PDAC protection (E0486) pending.

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