OrthoAccel® Technologies Inc, Houston, announced that it has received FDA clearance for its newest accelerated treatment device, AcceleDent® Optima, and will begin fulfilling orders immediately. The prescription only device is for patients undergoing orthodontic treatment with braces or aligners.
The AcceleDent Optima connects patients and practices with usage monitoring, direct messaging, and virtual rewards via the HIPAA-compliant AcceleDent App, which can be downloaded from iTunes and Google Play.
The third generation in the company’s vibratory accelerated orthodontic devices, the AcceleDent Optima features a smaller profile and is lighter in weight than previous devices. In addition, the device is waterproof and able to connect with smartphones and tablets through Bluetooth®.
The AcceleDent Optima includes a charging case that enables patients to wirelessly charge the activator, which has a 5 to 7 day battery life.
Like its predecessors, AcceleDent Aura and AcceleDent Classic, the Optima features the company’s patented Soft Pulse® Technology. According to the company, the pulsating forces stimulate cellular activity in orthodontic treatment and speed up bone remodeling.
The AcceleDent App allows patients to track their usage, set reminder notifications, and compare their progress with other AcceleDent patients worldwide. According to the company, patients who maintain optimal daily usage of the device will earn awards on the app’s Achievements Screen, which are similar to badges that users earn on popular fitness tracking apps.
Orthodontists, treatment coordinators, and other practice staff will be able to view a customizable web portal that syncs real-time usage for each of their AcceleDent patients.
In addition to its FDA clearance, AcceleDent Optima has also been cleared by Health Canada and has received the CE Mark that makes it commercially available in Europe.