Beam Brush, smartphone app gain FDA 510(k) clearance

By: Neil Versel | Jul 2, 2012        

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FDA-cleared Beam BrushThe Beam Brush, a Bluetooth-enabled toothbrush from Louisville, Ky.-based startup Beam Technologies, and a companion app have received 510(k) clearance from the Food and Drug Administration. The FDA on June 21 cleared the product for sale as a Class I medical device on and the company announced the clearance Friday.

Technically a manual toothbrush, the Beam Brush likely will go on sale this fall for a retail price of $50. However, CEO Alex Frommeyer says the company will offer the product at a pre-launch price of $35 through Beam’s website, Facebook page and Twitter feed. Replacement brush heads will cost $4; the companion app, for Apple iOS and Android, will be free.

A sensor on board the Beam Brush monitors when and for how long users brush their teeth, and then transmits the data over a Bluetooth connection to the smartphone app. “The app helps with personal management,” Frommeyer explains to MobiHealthNews. “You can forward that data to your dentist or hygienist.”

A rewards platform adds a gaming element by having people set goals or “compete” against others to improve the frequency and duration of their brushing. “If you accomplish that, I can give you a real-world prize,” Frommeyer says. This is a feature particularly useful for children ages 4-10, one of the product’s target markets, according to Frommeyer. “It’s also a great tool for adults,” he adds.

The product came together remarkably fast, and beat at least two other wireless sensing toothbrushes, one from Rice University and another from startup company GreenGoose, to FDA clearance. Frommeyer said he came up with the concept last summer and started serious development in the fall, so it was less than a year from idea to regulatory approval, perhaps because the Beam Brush technically is a manual toothbrush.

Frommeyer says he had “no issues” through the FDA review process, despite the fact that the agency issued a warning to consumers in February about parts flying off of the popular Spinbrush electric toothbrush and injuring users. The warning came down the same week Beam Technologies went public with its concept.