ClearSight hemodynamic monitoring system receives FDA clearance

Edwards Lifesciences Corporation announced that it has received FDA clearance for the ClearSight noninvasive hemodynamic monitoring system.

The ClearSight system is a noninvasive monitor intended to provide clinicians with information on blood volume and flow during surgery for patients at moderate or high risk for postsurgical complications, in whom invasive monitoring would not be used, according to a press release.

Use of the system “provides an opportunity to extend the benefits of hemodynamic optimization … to a broader patient population that could benefit from close monitoring, but may not receive it without a noninvasive option,” according to the release.

The system incorporates a cuff placed on the outside of the patient’s finger during the procedure, which is connected to the company’s EV1000 clinical platform to provide hemodynamic information without requiring the insertion of a device into the body. The technology and software used by the ClearSight system is similar to that used to noninvasively monitor BP in astronauts while in space, according to the release.

“Proper intraoperative management of moderate- and high-risk surgery patients is critical to help reduce the risk of post-surgical complications,” Julie K. Thacker, MD, surgical oncologist at Duke University Hospital, stated in the release. “Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimization protocols.”