Biolux Research has partnered with the Schulman Study Group to begin beta testing of its new OrthoPulse device. This device uses proprietary photobiomodulation technology and is designed to be used with orthodontic mechanics to reduce patient treatment time. The company anticipates FDA clearance as a class II medical device by early 2015 and launching OrthoPulse later next year.
Schulman Study Group members will test OrthoPulse in their practices in the U.S. and Canada. Both doctors and patients will give feedback on the use with fixed appliances or removable clear aligners. The beta evaluation program with the Schulman Study Group will be performed under an investigational protocol with independent ethics approval.
