FDA approves clinical trial wearables


https://i2.wp.com/www.pmlive.com/__data/assets/image/0005/543308/Camntech_Pro-Diary.jpg

US regulators have approved two new wristwatch-like devices for use in clinical trials.

Cambridge, UK-based firm CamNtech’s MotionWatch and Pro-Diary medical devices both use ‘accelerometer’ motion sensors to document physical movement.

The Pro-Diary (pictured) also has a built-in score pad to capture patient reported outcomes and which can be used instead of, or in addition to, traditional written patient diary in conjunction with activity monitoring.

They join CamNtech’s existing Actilheart and Actiwave devices on the market and have been cleared by the FDA “to assess activity in any instance where quantifiable analysis of physical motion is desired”.

Such uses could include monitoring limb or body movements during daily living and sleep.

A number of wearable devices have hit the consumer market in the last year or so, including Fitbit and Nike’s FuelBand but, as MobiHealthNews notes, the only consumer device to win FDA approval so far has been the BodyMedia CORE Armband.

Source: pmlive.com

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