In the United States, roughly one out of every three babies born in the United States are delivered via cesarean section. According to key stakeholders, nearly half of these c-section deliveries are medically unnecessary. These major surgeries carry risks such as postpartum hemorrhage, rupture of the uterus, cardiac arrest, infection, complications from anesthesia, and much more.
Raydiant Oximetry, Inc. is a California-based company that has developed a safe and noninvasive technology that directly monitors a baby’s oxygenation during pregnancy. For clinicians who are dissatisfied with the lack of tools available to assess the baby during childbirth, this technology will lead to improved decision making and better care to mother and baby. Today, the company is announcing that it has been awarded Breakthrough Device status by the Food and Drug Administration (FDA).
“The FDA’s approval for a Breakthrough Medical Device status is an incredible validation for the work that we are doing,” said Raydiant Oximetry CEO Dr. Neil P. Ray. “Not only does it accelerate the path towards FDA approval, it’s also a public health validation that what we have been developing is a global priority for the health of mothers and babies.”
The FDA’s Breakthrough program is targeted towards medical devices that address significant unmet clinical needs. It provides an expedited pathway to approval for market access. This pathway affords the sponsor a priority review with senior personnel and less pre-market clinical data for expedited approval.
“It is baffling that the public outcry over our current c-section rate isn’t louder than it is,” said AngelMD Lead Investor Dr. Wendy Whittington. “Raydiant’s new breakthrough status confirms that safe, effective tools to give doctors better information about in utero well being are necessary and timely. Tools to enable doing the right thing are welcome and necessary in this pivotal time for our healthcare system.”
AngelMD announced in September 2018 that a group of its investors had completed a funding round in Raydiant Oximetry. The company is now working on building its next generation prototype, to improve accuracy and reliability, which is slated for completion in February of 2019.