FDA clears two wristworn fitness trackers for clinical trials

By: Jonah Comstock | Feb 10, 2014        

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MotionWatchA British company, Camntech, has received FDA clearance for a motion-tracking wristband and a wristworn electronic diary, likely for use in clinical trials.

The devices are called the MotionWatch 8 and PRO-Diary. According to the filing, the devices “are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep.” The devices upload data to a PC via a USB cord.

Both devices sport a tri-axis accelerometer, but the MotionWatch is also waterproof and contains an ambient light sensor. The MotionWatch has a 6-month replaceable battery while the PRO-Diary has a 3-week rechargeable battery.

The PRO-Diary has an OLED screen and can be loaded with survey questions the patient can then answer right on the wrist. The device can also be set up with alarms that will prompt patients to answer questions at a specific time. The company said the technology has been validated against both paper and Palm Pilot-based surveys and tested favorably.

Camntech was founded in 1995 under the name Cambridge Neurotechnologies. The company also makes tools for tracking heart rate and ECG. Camntech’s previous motion tracking device, the ActiWatch, had a less advanced motion sensor and was only cleared to measure movement data during sleep, rather than during sleep and throughout the day.

Direct-to-consumer activity tracking devices like Fitbit, Nike FuelBand, and Jawbone UP, don’t typically secure FDA clearance — the one notable exception is the BodyMedia CORE Armband.