Cambridge-based diagnostics device maker Sphere Medical Holding announced that it has received the CE Mark approval to market its patient-attached arterial blood analyzer, Proxima system.
The Proxima system can be used in intensive care and the operating room to get real-time results of blood gas, hematocrit, and electrolyte measurements as often as necessary rather than sending the blood samples to laboratories for analysis.
Doctors can attach the system to the arterial line of the patient and tests can be initialized with the help of a touchscreen control panel which will also display the results. The doctors can initiate the test as many times as they want and there are no additional costs associated with each test, with the blood sample returned back into the patient after the test.
Stating that the approval for Proxima marks a major milestone for the company, Sphere Medical's CEO Wolfgang Rencken said, "A very considerable effort has gone into the CE marking process and today's announcement of its successful completion represents a significant milestone for the Company and is the beginning of Proxima's commercial future. This is an exciting time for the Company, its partners, investors and staff and I am delighted to have joined at such a pivotal time."