PMD-200

The PMD-200 (Nociception Level™ Index) aims to objectively monitor intraoperative nociception in anesthetized adult patients receiving opioids, thereby enabling optimized analgesic administration. It achieves this using an AI-driven algorithm that synthesizes data from multiple physiological parameters like photoplethysmogram and skin conductance into a single, actionable index (0-100).

The PMD-200, also known as the Nociception Level™ (NOL) Index, is a medical device designed to monitor the level of pain or nociception in adult patients who are under general anesthesia and receiving opioid analgesics. Its core methodology relies on an artificial intelligence-based algorithm that integrates data from multiple physiological signals, including photoplethysmogram, skin conductance, pulse amplitude, and perfusion. This combination produces a single numerical score, the NOL Index, ranging from 0 to 100, providing anesthesiologists with a continuous, objective measure of the patient's nociceptive state to guide analgesic administration, particularly when the index suggests an increase in nociception during surgery. Clinical validation of the PMD-200, conducted through both surgical patient studies and volunteer trials, has demonstrated its superior capability in detecting noxious events compared to monitoring systems that depend on only a single physiological parameter. By offering a composite and objective metric for pain, the PMD-200 facilitates more precise optimization of analgesia. This enhanced precision aims to mitigate the risks associated with both excessive and insufficient opioid dosing during surgical procedures, thereby improving patient management under anesthesia.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the AI algorithm specifically weigh each physiological signal (photoplethysmogram, skin conductance, pulse amplitude, perfusion) in calculating the NOL Index, and is this weighting dynamic or fixed?; What were the specific characteristics of the surgical and volunteer studies that validated the PMD-200, particularly concerning patient demographics, types of surgeries, and the nature of noxious stimuli applied?; Are there any known confounders or patient populations (e.g., those with autonomic dysfunction, specific medication regimens, or certain co-morbidities) where the NOL Index accuracy might be affected?; Beyond adjusting analgesic medication, what is the evidence for the PMD-200's impact on longer-term patient outcomes, such as post-operative pain, opioid consumption, or recovery times?; How does the PMD-200 differentiate between physiological responses to nociception versus other intraoperative stimuli or changes in patient state that might affect the measured parameters?