Raydiant Oximetry, a pioneering medical device company focused on improving childbirth outcomes for mothers and babies, has received FDA approval for an Investigational Device Exemption (IDE) for its Lumerah™ technology. This approval paves the way for an Early Feasibility Study (EFS) targeting pregnant women during labor and delivery.

Lumerah is an innovative, non-invasive fetal pulse oximeter designed to enhance the detection of fetal distress by measuring fetal blood oxygen levels. Traditional fetal heart rate monitoring, while widely used, has limitations in sensitivity and specificity for identifying fetal distress.

Insufficient sensitivity can result in undetected fetal distress and subsequent neurological injury in newborns due to lack of oxygen during birth. Raydiant Oximetry's CEO, Dr. Neil P. Ray, highlights Lumerah's potential to prevent such injuries, noting the significant number of affected babies annually in the United States.

Conversely, low specificity can lead to unnecessary emergency C-sections, increasing risks for both mothers and babies and driving up healthcare costs. Dr. Ray points out the role of current fetal monitoring techniques in driving these emergency procedures and their long-lasting effects on mothers and babies.

Early studies suggest that Lumerah has the potential to significantly improve sensitivity and specificity in detecting fetal distress, potentially reducing newborn neurological injuries and unnecessary C-sections. The device has been granted FDA Breakthrough Device Designation, expediting its path to market approval.

Supported by respected organizations such as the March of Dimes and the National Institutes of Health (NIH), Raydiant Oximetry aims to address the historical lack of breakthrough devices in obstetrics. Dr. Ray expresses enthusiasm about contributing to a transformative shift in women's healthcare.

Source: globenewswire.com

 

 

 

 

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