FDA OKs Wearable Monitor

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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.

Proteus Biomedical also is developing implantable and ingestible technologies to monitor patient status or compliance with a treatment regimen. Its Web site has an example of the uses of ingestible technology: "Proteus ingestible event markers (IEMs) are tiny, digestible sensors made from food ingredients, which are activated by stomach fluids after swallowing. Once activated, the IEM sends an ultra low-power, private, digital signal through the body to a microelectronic receiver that is either a small bandage style skin patch or a tiny device insert under the skin. The receiver date- and time-stamps, decodes, and records information such as the type of drug, the dose, and the place of manufacture, as well as measures and reports physiologic measures such as heart rate, activity, and respiratory rate."

Investors in the company include medical device maker Medtronic Inc., pharmaceutical firm Novartis, and silicon-based electronics manufacturer ON Semiconductor. More information is available at proteusbiomed.com.

--Joseph Goedert


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