FDA Approves New 3D Printed Device for More Comfortable Sleep Apnea Treatment

Airway Management, a U.S.-based medical device company that specializes in oral appliance therapy for sleep-disordered breathing, just received FDA clearance for its Nylon flexTAP, a new 3D printed oral appliance for treating mild to moderate obstructive sleep apnea and snoring. The device enters a rapidly expanding global market for sleep apnea treatments, which was valued in the billions and is projected to see significant growth over the next decade, highlighting a major opportunity for 3D printing in this market.

The Nylon flexTAP is a custom-manufactured, patient-specific device that’s 3D printed using medical-grade resin, which the company states is both BPA-free and metal-free.

A significant advantage for clinics is the simplified fitting process that can be achieved with digital 3D scans, and does not require a traditional bite registration. This efficiency can reduce chair time for both patients and dental practitioners, streamlining the treatment process. The device is manufactured in the United States and is available through Airway Labs.

A key feature of the device, the company says, is its patented designed to allow for both vertical and horizontal jaw movement. This movement helps to increase airway space, directly addressing the cause of obstructive sleep apnea.