A coming soon, watch this space item....
Sensors for Medicine and Science, Inc., a privately held medical device company focused on the development and commercialization of the first fully implantable, long-term continuous glucose monitoring announced its new company name, Senseonics.
http://senseonics.com/news/sensors-medicine-science-company-senseonics
it has submitted its pivotal clinical study protocol to the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Germany.
The pivotal study is titled PRECISE (Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor), and its objective is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring system over 180 days.
The PRECISE study requires clinical participants with diabetes to use the glucose sensor in the arm and to wear the external receiver to obtain continuous glucose readings during the 180-day study duration. The study will also evaluate safety of the Senseonics CGM system usage during in-clinic and home wear.
"All the study investigators are very much looking forward to proceeding with this first large study of a long-term implantable glucose sensor,"
Sensors for Medicine and Science, Inc., a privately held medical device company focused on the development and commercialization of the first fully implantable, long-term continuous glucose monitoring announced its new company name, Senseonics.
http://senseonics.com/news/sensors-medicine-science-company-senseonics
it has submitted its pivotal clinical study protocol to the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Germany.
The pivotal study is titled PRECISE (Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor), and its objective is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring system over 180 days.
The PRECISE study requires clinical participants with diabetes to use the glucose sensor in the arm and to wear the external receiver to obtain continuous glucose readings during the 180-day study duration. The study will also evaluate safety of the Senseonics CGM system usage during in-clinic and home wear.
"All the study investigators are very much looking forward to proceeding with this first large study of a long-term implantable glucose sensor,"