Proteus Biomedical nabs CE Mark for ingestible sensor

Proteus Biomedical logo

European Union doctors may now begin prescribing Proteus Biomedical Inc.’s “Raisins.”

The Redwood City, Calif.-based company won CE Mark approval for its ingestible “Raisin” sensor and personal physiologic monitor system.

Proteus also announced ISO 13485:2003 certification for the system, according to a press release.

The device has the ability to record any "discrete event," such as the ingestion of a specific pharmaceutical, along with other physiologic information such as heart rate and body angle. That information is then sent to a Bluetooth-enabled device, such as a smartphone, for mHealth applications, according to the company.

In April, Proteus won 510(k) clearance from the Food & Drug Administration for a wearable wireless monitor in the Raisin product family.

The company is also heralding the appointment of Arna Ionescu as director of product development and user experience. Ionescu is the former connected health domain lead of the IDEO design firm and will head Proteus’ new user experience group.

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