Healthcare Industry News: non-invasive patient monitor
News Release - August 25, 2009
CAS Medical Systems, Inc. Announces FDA 510(k) Clearance Expanding Labeling for FORE-SIGHT Cerebral Oximeter
FORE-SIGHT Now Indicated for Use On Neonates Weighing Less Than 2.5kgBRANFORD, Conn., Aug. 25, 2009 -- (Healthcare Sales & Marketing Network) -- CAS Medical Systems, Inc. (Nasdaq:CASM ) announced today a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its FORE-SIGHT(r) Cerebral Oximeter. The new labeling allows FORE-SIGHT to be used on all patients, including those weighing less than 2.5 Kilograms (kg).
The FORE-SIGHT Cerebral Oximeter is a Near Infra-Red Spectroscopy (NIRS) 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. FORE-SIGHT is the first and only device on the market today that provides a non-trend, absolute measure of cerebral tissue oxygen saturation for all patient populations regardless of age and weight.
"We currently use the FORE-SIGHT Cerebral Oximeter for clinical monitoring of term and near-term infants pre-ECMO and/or on ECMO, as well as infants with hypoxic-ischemic encephalopathy requiring cooling treatment for neuro-protection. Use of the FORE-SIGHT Cerebral Oximeter for patients below 2.5 kg will allow for clinical monitoring of smaller neonates potentially at risk for intra-ventricular hemorrhage, central apnea, and seizures," commented Dr. K. Rais-Bahrami, Director of the Neonatal-Perinatal Fellowship Program at Children's National Medical Center in Washington, DC.
Andrew E. Kersey, President and Chief Executive Officer of CASMED, stated, "We are pleased with the FDA's decision to expand clearance for the FORE-SIGHT Cerebral Oximeter to include patients below 2.5 kg. This expanded labeling will allow us additional access into the Neonatal ICU 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(tm) technology that protects fragile skin from heat, non-adhesive sensor solutions, and a very small sensor footprint -- the new, expanded labeling uniquely positions CASMED for acceptance in the Neonatal arena."
About CASMED(r) - Monitoring What's Vital
CAS Medical Systems, Inc. is a leading developer and manufacturer of medical devices for non-invasive patient monitoring. The Company's FORE-SIGHT Absolute Cerebral Oximeter is the first cerebral oximeter available with FDA clearance for non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation for neonates, infants, children and adults. This information helps avert brain damage or death during surgery and in critical care situations by allowing clinicians to identify patients with dangerously low levels of cerebral oxygen and intervene to reverse the condition.
The Company's product lines include the high-acuity monitoring capabilities of the FORE-SIGHT Cerebral Oximeter; the bedside patient monitoring line of vital signs and cardio-respiratory monitoring products, proprietary non-invasive blood pressure measurement technology, and supplies and service including blood pressure cuffs and products for neonatal intensive care. CASMED products are designed to meet the needs of a full spectrum of patient populations worldwide, ranging from adults to pediatrics and neonates.
For further information regarding CAS Medical Systems, Inc., visit the Company's website at www.casmed.com.
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future financial performance of the Company are subject to many factors including, but not limited to, the customer acceptance of the products in the market, the introduction of competitive products and product development, commercialization and technological difficulties, the impact of actions and events involving key customers, vendors and lenders, and other risks detailed in the Company's Form 10-K for the year ended December 31, 2008 and other subsequent Securities and Exchange Commission filings.
Such statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. When used in this press release the terms "anticipate", "believe", "estimate", "expect", "may", "objective", "plan", "possible", "potential", "project", "will" and similar expressions identify forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise.
Source: CAS Medical Systems
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