CAS Medical wins FDA clearance for expanded labeling of cerebral oximeter

Fri. August 28, 2009; Posted: 03:03 AM

Aug 28, 2009 (Datamonitor via COMTEX) -- CASM | Quote | Chart | News | PowerRating -- CAS Medical Systems has received a new 510(k) clearance from the FDA to expand the labeling for its Fore-Sight cerebral oximeter. The new labeling allows Fore-Sight to be used on all patients, including those weighing less than 2.5kg.

According to CAS Medical, the Fore-Sight cerebral oximeter is a near infra-red spectroscopy based device that non-invasively and continuously detects oxygen saturation changes in brain tissue, allowing clinicians to quickly react to reverse potentially harmful events before they become critical.

CAS Medical said that Fore-Sight is the first and only device that provides a non-trend, absolute measure of cerebral tissue oxygen saturation for all patient populations regardless of age and weight.

Andrew Kersey, president and CEO of CAS Medical Systems, said: "We are pleased with the FDA's decision to expand clearance for the Fore-Sight cerebral oximeter to include patients below 2.5kg. This expanded labeling will allow us additional access into the neonatal intensive care unit market, where a large percentage of at-risk patients have a low or very low birth weight.

"In conjunction with the unique benefits that the Fore-Sight small sensor offers - including Cool-Light technology that protects fragile skin from heat, non-adhesive sensor solutions, and a very small sensor footprint - the new, expanded labeling uniquely positions CAS Medical Systems for acceptance in the neonatal arena."

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