REDWOOD CITY, Calif.--()--Proteus Biomedical Inc., a pioneer in intelligent medicine, announced today that it has received CE Mark approval to market its ingestible sensor and personal physiologic monitor system in the European Union. The CE Mark certifies that the Proteus system has met European Union consumer and health requirements. Proteus also received ISO 13485:2003 certification for the design, development and manufacture of its product system.
“CE Mark approval represents a significant achievement for Proteus, and a major milestone for the advancement of intelligent medicine”
Proteus’s ingestible sensor and personal monitor system, called the RaisinTM System, is indicated under the CE Mark to timestamp, via ingestion, any discrete event (such as the ingestion of a specific pharmaceutical) and to record this event along with physiologic information such as heart rate, activity, body angle and patient-logged information. The unique ingestion event and personalized physiologic information are then communicated via Bluetooth to any computerized device, such as a mobile phone for emerging mHealth applications.
The Raisin System is being developed as part of Proteus’s integrated intelligent medicine system to link sensor-based formulations of pharmaceutical products to individualized physiologic response and outcomes-based treatment systems. Proteus and its partners are currently developing these integrated product systems in diabetes, cardiovascular disease, psychiatric disorders, organ transplantation and infectious disease.
As part of its development and commercialization of the Raisin System, Proteus also announced today the creation of a new product development group focused on user experience. Arna Ionescu, formerly Connected Health domain lead at the global design firm IDEO, has joined Proteus as Director, Product Development, User Experience. She will lead a team focused on applying the principles of human-centered design to create intelligent medicine products that empower consumers and transform the delivery and management of health care. Ms. Ionescu also teaches product and interaction design at Stanford University and California College of Art.
“CE Mark approval represents a significant achievement for Proteus, and a major milestone for the advancement of intelligent medicine,” said Andrew Thompson, president and chief executive officer of Proteus. “As we commercialize our products and empower patients and their families we will begin to realize the potential of a more connected, pervasive and personalized standard of care that promotes better access, higher value for money and more sustainable innovation models. The timing is very good – many government health budgets are under financial pressure and our approach is one that promises better results with less spending and higher consumer satisfaction.”
About Proteus Biomedical
Proteus Biomedical is pioneering intelligent medicine, an emerging field of advanced therapeutics that integrates in-body computer, sensor and communications technologies into existing pharmaceutical and medical device products. Proteus’s proprietary computing and sensing technologies enable proven therapies to be personalized, offering broad potential benefits across a range of care settings and therapeutic areas, including cardiovascular, psychiatric, metabolic and neurologic disorders.
More information about Proteus Biomedical can be found at www.proteusbiomed.com
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