Medasense’s NOL Device to Measure Pain in Anesthetized Patients OK’ed

Israeli company Medasense Biometrics has been granted U.S. Food and Drug Administration (FDA) marketing authorization for its PMD-200 patient monitor with NOL (nociception level index) tech developed to monitor the physiological response to pain via the de novo premarket review pathway.
 
NOL leverages a multi-parametric sensor platform and advanced artificial intelligence (AI) algorithms to convert complicated data into a patient’s “Signature of Pain.” It’s used in operating rooms and high-acuity settings where patients under anesthesia and not able to communicate, letting clinicians personalize pain management, control pain, and avoid overmedication.
 
According to the company, NOL is the first and only market-authorized, adjunctive technology for assessment of changes in nociception in adult patients receiving opioid or opioid-sparing analgesics.
 
“NOL technology has the potential to improve the lives of hundreds of millions of patients worldwide, and we have already seen the impact it has had in multiple countries,” Galit Zuckerman-Stark, CEO and founder of Medasense told the press. “Our mission is to help patients suffer less from pain and the adverse effects of pain medication. We are proud to offer the first and only measure of intraoperative pain (nociception) in the U.S., and to be able to offer meaningful innovation in the area of pain management to help patients undergoing surgery experience improved pain-related outcomes.”
 
“The anesthesia community has needed a technology like NOL for a long time,” sadded Frank Overdyk, MSEE, MD, Charleston, S.C. “We have devices that monitor depth of anesthesia, we have TOF cuffs to check for patient movement, but the missing piece of the puzzle is a way to monitor the effect of the opioid or opioid sparing analgesia. Relying on patient’s heart rate and blood pressure is neither specific nor sensitive enough to pain. This technology as an adjunctive to clinical judgment will provide a window into the patient’s nociceptive state during surgery so we can personalize the way we administer analgesia, improving the patient’s recovery.”
 
The authorization was supported by pivotal clinical data showing NOL-guided intraoperative analgesia as an adjunct to clinical judgment with clinical and vital signs resulted in better postoperative pain scores in the post-anesthesia unit in adult patients.