The Food and Drug Administration has given 510(k) clearance to Proteus Biomedical Inc. to market the Raisin Personal Monitor, a wireless personal, wearable health status-recording device.
The monitor attaches to skin with an adhesive layer and is worn like a bandage. It records such data as heart rate, respiration rate, physical activity, and body position, which is transmitted via Bluetooth technology to a mobile phone or other computing device.
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