Published on October 14, 2009 at 1:59 AM
Luminous Medical, Inc. announced today that it has reached agreement with a major supplier of electrochemical sensors for exclusive rights to incorporate its glucose sensor into Luminous' automated blood glucose monitor. Luminous is developing its monitor to enable clinicians to control hyperglycemia in critical care patients around the world.
Previously, Luminous was planning to use a sensing technology based on near-infrared spectrometry. "More than a year ago we realized that it was going to be difficult to gain FDA clearance for any novel glucose technology for use in the critical care environment," said Richard Thompson, president and CEO of Luminous Medical. "Our new approach uses standard, calibratable glucose oxidase chemistry with which the agency is very familiar."
Luminous has already incorporated the glucose oxidase sensing technology into its design and is preparing for pivotal clinical trials and a 510k application in 2010. "We were fortunate that we could modify our product to accept the new sensing technology," said Bill Patterson, Vice President of R&D. "The sensor is already being used in a product that has been cleared by the FDA to measure glucose in the ICU, which makes our development process straightforward."
Glucose oxidase electrochemistry has been used to measure glucose with near laboratory accuracy in point of care devices for many years. The FDA has recently expressed concern about the use of test strip based glucose meters that are not cleared to manage glucose in hospitalized patients. The Luminous product is being designed to automate the process of glucose monitoring while simultaneously raising the bar for measurement accuracy at the point of care.
SOURCE Luminous Medical, Inc.