FDA Cleared Neuro

FDA OKs smart cable for Edwards Lifesciences brain oxygenation sensor

Edwards Lifesciences (NYSE:EW) said today that it won 510(k) clearance from the FDA for a smart cable to connect a brain oxygenation sensor with its HemoSphere patient monitor.

The clearance covers the ForeSight tissue oximeter the Irvine, Calif.-based company acquired in the $98 million buyout of Casmed last April.

“Understanding the relationship between the heart and the brain can provide valuable patient insights to support decision making during a surgical procedure,” critical care VP Katie Szyman said in prepared remarks. “With the addition of the ForeSight sensors to Edwards’ most modern platform, HemoSphere, we can offer clinicians a broad range of smart hemodynamic management solutions to help improve patient care.”

“During surgical procedures where patients can not convey symptoms of reduced brain perfusion due to general anesthesia or sedation, decreased oxygen levels in the brain can have lasting effects and could result in complications as well as increased time spent in the hospital,” added Dr. Charles Hogue of Chicago’s Northwestern University Feinberg School of Medicine. “Combining advanced hemodynamic monitoring with tissue oximetry provides a more complete view of patients’ oxygen levels and oxygen use, allowing clinicians to optimize care for their patients throughout a procedure.”

Hogue is a paid consultant for Edwards, the company said.

Original Article: (https://www.massdevice.com/fda-oks-smart-cable-for-edwards-lifesciences-brain-oxygenation-sensor/)

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