Global law firm Hogan Lovells advised Medasense Biometrics Ltd. (Medasense), an Israel-headquartered medical device company dedicated to pain management, in securing Food and Drug Administration (FDA) De Novo premarket authorization for Medasense’s PMD-200 patient monitor with NOL® technology, developed for monitoring nociception, the physiological response to pain. Following the De Novo authorization, the NOL® technology became 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® uses a unique multi-parametric sensor platform and advanced AI algorithms to convert physiological signals into a proprietary index regarding a patient’s nociception level. The index allows clinicians to better personalize pain management by tailoring the administration of opioid-based analgesics in anesthetized patients.
The FDA market authorization, which was granted 17 February, was supported by pivotal clinical data demonstrating that NOL guided intraoperative analgesia as an adjunct to clinical judgment with clinical and vital signs resulted in improved postoperative pain scores in the post- anesthesia care unit in adult patients. The device is available worldwide and now will soon be available in the U.S. following FDA authorization.
The Hogan Lovells team for Medasense included Washington D.C.-based Medical Device regulatory partners Jonathan Kahan and Lina Kontos. The De Novo grant for Medasense is 1 of only 2 De Novo requests to have a successful outcome in this FDA review division in the last 5 years.
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