Medasense Biometrics Ltd. announced today (23rd Feb. 2023) 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 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.”