IVD Offering Anesthetic Breakthrough Receives CE Mark

The world’s first POC diagnostic for enabling the safe delivery of personalized dosages of IV anesthetic has received the CE mark, according to the UK-based developer of the technology. Sphere Medical of Cambridge, England, says the Pelorus 1500 IVD rapidly measures the concentration of the anesthetic propofol in patients’ blood samples. Sphere claims the device is the first that allows anesthesiologists to accurately determine exact dosages of the widely used IV drug.

The Pelorus 1500 most likely will be used with existing dosing pumps, Sphere says. The company cites clinical studies revealing that a single measurement during general anesthesia significantly improves clinicians’ understanding of propofol levels during an operation. While anesthetic gas monitoring is a standard procedure, an equivalent measurement of propofol and other IV anesthetics does not exist, the company notes.
Stuart Hendry, CEO of Sphere Medical, says now that the device has received the CE mark the company intends to “capitalize on early interest being shown by a number of medical device companies.” Sphere is also working with several leading anesthesiologists, he says.
 
---John Conroy