Proteus Biomedical, a provider of intelligent medicine, has received CE mark approval for its ingestible sensor and personal physiologic monitor system, Raisin System.
Proteus Biomedical has also received ISO 13485:2003 certification for the design, development and manufacture of its product system.
Proteus Biomedical said that the Raisin System is indicated under the CE mark to timestamp, via ingestion, any discrete event and to record the event along with physiologic information such as heart rate, activity, body angle and patient-logged information.
The Raisin System is being developed as part of Proteus’ integrated intelligent medicine system to link sensor-based formulations of medical products to individualized physiologic response and outcomes-based treatment systems.
Proteus Biomedical and its partners are currently developing the 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 Biomedical also reported the creation of a new product development group focused on user experience.
Proteus Biomedical president and chief executive officer Andrew Thompson said that the CE mark approval represents a significant achievement for Proteus, and a major milestone for the advancement of intelligent medicine.
“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,” Thompson said.
“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.”