Profile: LMS Medical Systems is a healthcare technology company specializing in computer software for obstetrical management. Our CALM™ system (computer assisted labor monitoring) integrates data from multiple sources. The CALM curve provides analysis of labor progression to help clinicians determine whether or not a caesarean section is appropriate for women demonstrating symptoms of dystocia (slow labor). The CALM patterns contain specialized algorithms & neural networks that detect & measure patterns in fetal heart rate recordings, including baseline, accelerations, decelerations, and variability. These events are interpreted using rule-based systems to help identify the fetus at risk for brain injury from oxygen deprivation. The CALM shoulder screen algorithms estimate the risk of shoulder dystocia with permanent injury based mainly on anthropometric maternal and fetal characteristics. We also provide the framework to transform the safety culture within obstetrical labor and delivery units.
FDA Registration Number: 9615396
US Agent: Matthew Sappern / Perigen Inc.
Phone: +1-(984)-209-4250 Fax: +1-(877)-327-0084 E-Mail:
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• Perinatal Monitoring System (FDA Code: HGM / 884.2740) A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts. |