The US Food and Drug Administration (FDA) has cleared a device from a new company to the oral appliance space, Achaemenid LLC, by granting two variants of its RADx mandibular repositioner 510(k) clearance for mild to moderate obstructive sleep apnea and snoring in adults.
Though most dental sleep medicine practitioners may not have heard of Achaemenid before, they recognize the name of its founder, Reza Radmand, DMD, FAAOM, who has held faculty positions at including UCLA School of Dentistry, Yale-New Haven Hospital Department of Dentistry, and as a research collaborator at Harvard Medical School’s Brigham and Women’s Hospital, division of sleep medicine.
The RADx is a custom oral sleep appliance with proprietary anatomical rotational hinged attachments, similar to shoulder or hip joints, providing a wide range of motion.
There are two variants of the device. The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms. The RADx White Night-p was designed with the upper and lower housing in one piece; the fixed upper tray-arm combination is the progressive part.
Achaemenid is also working on a prototype of a closed-loop custom oral appliance with wireless biosensors.
