FDA Clears First Device That Measures Pain In Anesthetized Patients

by Mat Dirjish

Global tech company Medasense Biometrics Ltd. announced that  the US Food and Drug Administration (FDA) approves the company’s PMD-200 patient monitor with NOL technology for  monitoring nociception, which is the physiological response to pain. Authorized through a De Novo grant, NOL uses a multi-parametric sensor platform and artificial intelligence (AI) algorithms to convert data into an anesthetized patient’s pain signature.

In operating rooms and high-acuity settings where patients are under anesthesia and unable to communicate, the PMD-200  enables clinicians to personalize pain management, control pain, and avoid overmedication. According to Medasense Biometrics, 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.

The FDA authorized PMD-200 monitor with NOL technology for measuring the physiological response to pain.

Studies indicate that intraoperative NOL monitoring can reduce postoperative pain for patients in the post anesthesia care unit and potentially reduce care costs. Other studies show that the odds of suffering severe post-operative pain are six times lower with NOL monitoring.

As per the company, approximately 50% of surgical patients suffer from moderate to severe postoperative pain and 12% suffer adverse events due to pain relief medication. These can result in longer hospitalization, additional healthcare costs, and a 50% increase in hospital readmissions.

Galit Zuckerman-Stark, CEO and founder of Medasense said, “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.” Frank Overdyk, MSEE, MD, Charleston, SC, adds, “The anesthesia community has needed a technology like NOL for a long time. 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 a 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 FDA market authorization has the support of pivotal clinical data demonstrating that NOL-guided intraoperative analgesia results in improved postoperative pain scores. For deeper details and data, peruse the PMD-200 overview.

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