Agency Clearance Paves Way for Commercialization in the United States of First and Only Authorized Device to Measure Pain in Anesthetized Patients Undergoing Surgery
RAMAT GAN, Israel, Feb. 23, 2023 /PRNewswire/ — Medasense Biometrics Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to the PMD-200 patient monitor with NOL® technology developed for monitoring nociception (the physiological response to pain) through the De Novo premarket review pathway.
NOL uses a unique multi-parametric sensor platform and advanced AI algorithms to convert complicated data into a patient’s ‘Signature of Pain.’ The technology, which is currently utilized in operating rooms and high-acuity settings, where patients are under anesthesia and unable to communicate, enables clinicians to personalize pain management, control pain and avoid overmedication. NOL is the first and only market-authorized, adjunctive monitoring technology for the 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,” said Galit Zuckerman-Stark, CEO & founder of Medasense. “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 US, and to be able to offer meaningful innovation in the area of pain management to help patients undergoing surgery experience improved pain-related outcomes.”