CamNtech has received FDA approval for two wrist-worn products to monitor patient activity for clinical purposes and in research trials. First is the MotionWatch 8, a small and light-weight waterproof wrist-worn device that uses a digital tri-axial accelerometer to monitor patient activity, similarly to many consumer fitness trackers. Furthermore, it contains a light sensor and activity marker. Data can be transferred to a PC using a USB connection. Accompanying software converts the data into activity plots to quantify the intensity and duration of daily physical activity. Example use cases indicated by CamNtech include as an indicator of a particular lifestyle, to monitor the effects on mobility of a medical condition or efficacy of its treatment, or to identify irregular activity patterns for assessment of sleep quality.
The second cleared device is the PRO-Diary, a compact wrist–worn electronic diary which also integrates the same activity monitor as the MotionWatch. The PRO–Diary features an OLED screen along with a touch sensitive slider and two buttons, which enables patients to answer questions at any moment of the day. Questionnaires are uploaded to the device via USB and questions can be asked at given times, random times or can be user initiated. The PRO-Diary has a battery life of two weeks. By being on the patient’s wrist at all times, the PRO–Diary should result in higher levels of compliance than paper based or other electronic alternatives.
Press release: MotionWatch and PRO-Diary gain FDA clearance…
Product pages: MotionWatch 8…; PRO-Diary…