Biolux Research, Vancouver, Canada, announced that its new product, the OrthoPulse,™ has received a Medical Device License from Health Canada and is now commercially available in Canada. OrthoPulse was approved as a Class 2 medical device according to the Canadian medical device regulations. In addition, the company recently updated its ISO 13485 scope of operations to include devices for use in orthodontics.
The OrthoPulse utilizes photobiomodulation, or light therapy, to reduce orthodontic treatment time. Biolux reports that the device uses low levels of near-infrared light energy to stimulate the periodontium and alveolar bone surrounding the roots of the teeth and increase bone regeneration and turnover, thus accelerating tooth movement and reducing treatment time for braces or clear aligners. Biolux’s clinical goal is to reduce average orthodontic treatment timelines by an average of two-thirds.
The OrthoPulse is a self-treatment device that patients use at home, designed for a daily treatment of 10 minutes. It can be used with any type of orthodontic mechanics, including brackets/wires and clear aligners. It’s battery operated, includes no buttons or wires, and communicates wirelessly to an Apple iOS app to enable the patient and doctor to monitor and track usage compliance and orthodontic treatment progress.
