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FDA provides LMS clearance for new core product


News Article
Published: February 2005
Sector: Press Release

MONTREAL, Feb. 22 /PRNewswire-FirstCall/ -- LMS Medical Systems (AMEX:LMZ) , a healthcare technology company and developer of the CALM(TM) system (Computer Assisted Labor Management) today announced that it has received clearance from the United States Food & Drug Administration to market Patterns(TM), a new and innovative decision support software tool specifically directed at the health of the fetus.

Fetal distress during labor is recognized as one of the greatest complexities of childbirth and therefore a significant issue in so far as risk management is concerned. During labor and delivery, abnormal patterns in the fetal heart rate tracing can indicate fetal distress and thereby lead to interventions such as more diagnostic tests or delivery by cesarean section. Patterns(TM) uses the power of computers to provide objective, real-time detection, classification and labeling of fetal heart rate patterns. Better assessment of fetal distress may reduce the incidence and severity of birth related brain damage.

"Clinicians use fetal heart rate recordings to assess the baby's tolerance to labor. Providing quality obstetrical care requires appropriate and timely responses to tracing abnormalities." said Dr. Emily Hamilton, Vice- President, Medical Research and founder of LMS. "We have designed Patterns(TM) to assist clinical teams, by providing continuous analysis of these tracings day or night and drawing the attention of healthcare users to important parts of the tracing."

As a core technology, Patterns(TM) can be used in a standalone fashion or as an integrated module of the LMS Clinical Information System. Protected by patents pending, Patterns(TM) may also be used during the final stages of pregnancy in a medical practitioner's office for high risk cases. Initial availability of the product is scheduled for Q3 2005.

LMS has now received regulatory clearance for two of the three products that form its proprietary Decision Support Suite. The first product, Curve(TM), which provides an objective assessment of the progress of labor, is in commercial use. Patterns(TM) is scheduled for general availability late summer. The third and final component, ANNI(TM), a neural network that assesses the risk of fetal damage, will commence regulatory file preparation this spring in anticipation of an FDA submission later in the year.

About LMS: LMS is a leader in the application of advanced mathematical modeling and neural networks for medical use. The LMS Decision Support Suite provides physicians, nursing staff and risk managers with clinical information systems and decision support tools designed to improve outcomes and patient care for mothers and their infants during labor and delivery.

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