CAS Medical Systems, a manufacturer of non-invasive, patient monitoring medical devices, has announced that it has received clearance from the US Food and Drug Administration to market the FORE-SIGHT Oximeter.
The FORE-SIGHT Oximeter can ascertain the absolute hemoglobin oxygen saturation in a newborn’s abdomen. In newborns, low oxygen saturation levels are associated with multiple organ injuries than can have a long-term impact on the child.
The President and Chief Executive Officer of CAS Medical (CASMED), Thomas M. Patton expressed delight by stating that the FORE-SIGHT Oximeter is the first absolute tissue oximeter with an abdominal claim to receive an FDA clearance. Patten further explained that it took several years of clinical study to develop an algorithm specific to abdomen monitoring for low birth weight and preterm babies weighing less than 4 kg.
In the US, around 400,000 premature babies are born every year. Preterm and babies with low birth weight are often under developed and require a monitoring solution since they are highly susceptible to injury and irregular blood flow results in low oxygen levels in their abdominal and brain tissue.
The Director – Neonatal Perinatal Fellowship Program at the Children National Medical Center located in Washington, D.C., Dr. K. Rais-Bahrami commented that the CASMED oximeter solution offers clinicians a reliable and non-invasive monitoring solution for treating preterm infants.
The FORE-SIGHT Absolute Tissue Oximetersfor neonatal abdomen monitoring is likely to be available in Q2 of 2012.
Source: http://www.casmed.com