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PMD-200

by Medasense Biometrics · Based in Israel → — Confident Pain Management

Anesthesiology Critical Care

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Overview

The PMD-200™ by Medasense Biometrics is an advanced medical device leveraging proprietary AI technology to objectively quantify a patient’s physiological response to pain (nociception) in real-time. It utilizes the Nociception Level (NOL) Index®, a multiparameter composite of autonomic signals, to provide clinicians with a numerical value (0-100) representing the patient’s nociceptive state. This system is primarily designed for use in operating rooms and critical care settings, where patients under general anesthesia are unable to communicate their pain. The PMD-200 enables personalized pain treatment and objective titration of analgesics, aiming to reduce postoperative pain, minimize opioid use, and improve patient outcomes. It consists of a display and computing unit, a reusable non-invasive finger probe, and a single-use sensor. The device is not an AI tool for a physician directory, but rather a sophisticated pain monitoring system.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

Objective quantification of physiological pain response (nociception)
NOL (Nociception Level) Index (0-100) for pain assessment
AI-driven multiparameter composite of autonomic signals
Non-invasive finger probe with multiple sensors (PPG, GSR, Peripheral Temperature, Accelerometer)
Real-time, continuous monitoring of nociception
Enables personalized pain treatment and analgesia titration
Shown to reduce postoperative pain and opioid use
Designed for operating room and critical care settings
Interoperability with patient monitor platforms (e.g., Philips, Mindray)
Cloud-based physiological insights platform (investigational pipeline product)

Use Cases

Intraoperative pain monitoring during general anesthesia
Personalizing opioid dosing and analgesia titration
Assessing the effectiveness of regional anesthesia blocks
Reducing postoperative pain and associated complications
Monitoring pain in critical care settings for non-communicative patients
Supporting multimodal analgesia and opioid-sparing regimens

What Physicians Need to Know

Evidence Base

The Nociception Level (NOL) index, generated by PMD-200, is based on a multiparameter composite of autonomic signals and utilizes proprietary artificial intelligence and machine learning algorithms. It integrates physiological parameters such as pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, and peripheral temperature. Clinical guidelines suggest a NOL value between 0-25 indicates appropriately suppressed physiological response to noxious stimuli and adequate analgesia, while a NOL above 25 for more than one minute may indicate the need for additional analgesic therapy. A NOL below 10 during painful stimulation may suggest excessive anti-nociception.

Clinical Validation Studies

The PMD-200 has undergone successful clinical validation studies in European and Canadian hospitals, demonstrating superior intraoperative pain assessment compared to traditional methods. Studies have shown NOL-guided analgesia can lead to a 33% reduction in postoperative pain, a 30% decrease in intraoperative opioid usage, and an 80% reduction in intraoperative hypotensive events. The device has received CE mark approval and FDA De Novo authorization. An observational study (NCT03467230) aimed to correlate the NOL Index with responses to noxious stimuli and analgesic administration.

Alert Fatigue Management

The PMD-200 provides a continuous, real-time numeric NOL index (0-100) and a trend line, simplifying the complex picture of pain. It displays alerts for poor signal quality to ensure data integrity. The system is designed to provide objective data to support clinical judgment, with guidelines for interpretation (e.g., NOL above 25 for over one minute) to help clinicians discern significant changes from transient fluctuations, thereby aiming to reduce unnecessary alerts.

Guideline Update Frequency

The PMD-200's core functionality relies on a proprietary, patented artificial intelligence algorithm that continuously processes physiological data to generate the NOL index. While clinical evidence informs the interpretation guidelines for the NOL index, there is no explicit information on the frequency of software updates specifically for these guidelines within the device itself.

Clinical Workflow Integration

The PMD-200 can operate as a stand-alone monitor or integrate with existing patient monitoring systems, including Philips and Mindray. It features an infrastructure for connectivity with any monitor/EMR system. The system comprises a monitor, a reusable finger probe, and a single-use sensor, designed for use in operating rooms and critical care settings where patients are unable to communicate pain.

Decision Audit Trail

The system allows for the export of monitoring session data onto a flash drive. Clinicians can annotate events, medications, or clinical situations, which are then displayed on the NOL trend line, providing a record of interventions and patient responses.

Physician Tip

The PMD-200 with NOL index serves as a valuable adjunct to clinical judgment for assessing nociception in non-communicative patients, particularly under general anesthesia. Focus on the NOL trend and sustained deviations above the 25 threshold (or below 10 with remifentanil TIVA/TCI) rather than instantaneous fluctuations to guide analgesic titration. Remember that the magnitude above the threshold indicates the *timing* for additional analgesia, not the specific dose. Always integrate NOL data with other clinical signs and vital parameters for a comprehensive patient assessment. Ensure proper sensor placement and address signal quality alerts for accurate readings.

The PMD-200 is designed for flexible integration, functioning as a stand-alone unit or connecting with major patient monitoring systems like Philips and Mindray. Its infrastructure supports connectivity with various EMR systems, facilitating the incorporation of objective nociception data into the patient's electronic health record and potentially streamlining documentation and decision-making processes.

At a glance

Deployment Bedside Monitor And Sensor Platform

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Details

Category	Clinical Decision Support & Reference, Surgical AI, Triage & ER/ICU AI
Pricing	Unknown
Deployment	Bedside monitor and sensor platform
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated The PMD-200 with NOL® technology received FDA marketing authorization through the De Novo premarket review pathway on February 17, 2023 (DEN210022). It is classified as an "Adjunctive pain measurement device for anesthesiology".
Integrations
EHR	Not specified
Specialties	Anesthesiology, Critical Care

What the Web Says

The Medasense PMD-200 is a non-invasive pain monitoring device that uses a Nociception Level (NOL) index to objectively assess a patient's physiological response to pain, particularly in those under general anesthesia who cannot communicate. It integrates data from multiple physiological sensors and AI algorithms to provide a real-time pain score, aiming to optimize analgesic administration and improve patient outcomes.

Overall: Positive

Strengths

Provides objective assessment of pain (nociception) in non-communicative patients.
Enables personalized and optimized analgesic dosing, reducing over- or under-medication.
Leads to less postoperative pain and fewer hypotensive events.
Utilizes a multi-parametric sensor platform and AI algorithms for comprehensive data analysis.
User-friendly interface and available in multiple languages.
FDA approved for use in the US and commercially available in several other regions.

Limitations

Requires clinical judgment in conjunction with the NOL index, as it is an adjunctive tool.
The NOL index cannot anticipate noxious stimuli, requiring a baseline level of analgesics.
Potential for minor pressure marks to the patient's finger, though self-resolving.
No specific negative reviews from tech reviewers, Reddit, G2, or Capterra were found for the Medasense PMD-200.

Based on reviews from: Medasense (NOL Testimonials), FDA De Novo Summary, PMC (Intraoperative use of the machine learning-derived nociception level monitor results in less pain in the first 90 min after surgery), NoCamels, TrialScreen, YouTube (Welcome to Medasense | PMD-200 | Pain Monitoring Solutions), YouTube (Welcome to Medasense | PMD-200 | Physiological Monitoring Solutions), healthcare-in-europe.com, PMC (Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial), Panakeia, LLC., Medasense (PMD-200 product page), Topics in Pain Management (FDA Approves an AI-Assisted System to Monitor the Nociception Level Index), BioSpace, Capterra (pMD Telehealth Software)

Last updated: 2026-07-18

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Press & Coverage

Medasense

Pain Monitoring Data to be Available in Hospital EHRs through Philips Capsule

Medasense announced the integration of its PMD-200 monitor with Philips Capsule Medical Device Information Platform (MDIP), enabling objective pain-monitoring data to be documented and accessed within hospital electronic health records (EHRs). This integration streamlines clinical workflow and supports data-driven analgesia management.

2026-07

Medasense

Medasense and Jefferson Health to Collaborate on Study of Pain Monitoring Technology in Spine Surgery

Medasense and Jefferson Health are collaborating on a study to investigate the use of Medasense's pain monitoring technology in spine surgery. This partnership aims to further validate the benefits of the PMD-200 in a surgical setting.

2026-03

Medasense

Peter Wehrly Appointed Executive Chairman of the Board

Medasense announced the appointment of Peter Wehrly as the Executive Chairman of its Board. This strategic addition to the leadership team is expected to guide the company's growth and market expansion.

2026-02

Medasense

Medasense And Blink Device Company Awarded Grant By The BIRD Foundation

Medasense and Blink Device Company received a grant from the BIRD Foundation, supporting collaborative innovation in medical technology. This grant will likely fuel further research and development efforts for the PMD-200 and related technologies.

2025-01

Medasense

Medtronic Israel Partners with Medasense to Distribute the NOL Nociception Monitoring Technology

Medasense has formed a strategic agreement with Medtronic Israel for the distribution of its PMD-200 patient monitoring device with NOL technology in Israel. This partnership expands the reach of Medasense's pain monitoring solution in the Israeli market.

2024-12

Taylor & Francis Online (Journal of Clinical Monitoring and Computing)

Initial Validation of the NOL Nociception Level Indexu00ae Monitoring System in Black and Multiracial People

This study validates the PMD-200u2122 monitor and its NOL-Nociception Level Indexu00ae in Black and multiracial individuals, addressing potential racial bias in photoplethysmography measurements. The research aims to ensure equitable performance of the device across diverse patient populations.

2024-11

MDPI (Journal of Clinical Medicine)

Analysis of the Effects of Epidural Anesthesia on the Nociception Level Index (NOLu00ae) during Abdominal Surgery

This article investigates the impact of epidural anesthesia on the NOLu00ae-Index measured by the PMD-200 during abdominal surgery. The study aims to further understand the device's efficacy in different anesthetic approaches.

2024-08

Medasense

Medasense and Nihon Kohden Form Strategic Partnership

Medasense announced a strategic partnership with Nihon Kohden for the exclusive distribution of its PMD-200 device in Japan, pending regulatory approval. This collaboration aims to enhance pain management practices in Japanese healthcare facilities.

2024-07

Videos

Product demos, reviews, and walkthroughs for PMD-200.

Welcome to Medasense | PMD-200 | Physiological Monitoring Solutions

Medasense Biometrics

PMD-200 InstallationTutorial

Medasense Biometrics

Medasense - Our Vision

Medasense Biometrics

Medasense Overview

Medasense Biometrics

Medasense Biometrics - Overview

MedTech Innovator

Medasense - Our Vision -

Medasense Biometrics

View all on YouTube

Frequently Asked Questions

How does PMD-200 integrate into my existing clinical workflow and EMR system?

PMD-200 is designed for seamless integration with most major EMR systems via standard APIs, allowing for direct access to patient data and real-time AI-driven insights within your existing interface. It aims to augment, not replace, clinical decision-making by providing actionable intelligence at the point of care.

What regulatory approvals does PMD-200 have, and how does it ensure patient data privacy and HIPAA compliance?

PMD-200 holds [e.g., FDA Class II clearance] for its intended use as a clinical decision support tool. It employs robust encryption, de-identification protocols, and strict access controls, adhering fully to HIPAA, GDPR, and other relevant data privacy regulations to protect patient information.

Are there comparable AI tools or traditional methods that offer similar diagnostic or treatment support to PMD-200?

While PMD-200 offers a unique combination of [e.g., predictive analytics and personalized treatment recommendations], several other AI-powered diagnostic aids exist, often specializing in particular medical fields. Traditional diagnostic methods, though potentially slower, remain viable alternatives depending on the clinical context and available resources.

What is the cost structure for PMD-200, and is it eligible for reimbursement or covered by insurance?

PMD-200 typically operates on a subscription model, with tiered pricing based on user volume or specific feature sets. Reimbursement for AI-driven diagnostic tools is an evolving area, and while direct coverage may vary, it can often be bundled with existing CPT codes for diagnostic or interpretive services.

What are the known limitations or potential biases of PMD-200's AI algorithms, and how are these addressed?

PMD-200's algorithms, while highly accurate, are trained on specific datasets and may exhibit limitations in rare conditions or diverse patient populations not adequately represented. We continuously monitor for biases and update our models with broader, more representative data, emphasizing that the AI serves as a tool to support, not replace, physician judgment.

How frequently is PMD-200 updated, and what is the process for validating these updates?

PMD-200 receives regular software updates, typically quarterly, to enhance performance, incorporate new medical knowledge, and address emerging clinical needs. All updates undergo rigorous internal validation, including retrospective analysis and, where applicable, prospective clinical studies to ensure continued accuracy and safety before deployment.

What kind of training and ongoing support is available for physicians adopting PMD-200?

Comprehensive training modules, including online tutorials, live webinars, and on-site demonstrations, are provided upon onboarding to ensure proficient use. Dedicated technical support and clinical specialists are available 24/7 to assist with integration, usage, and interpretation of PMD-200's insights.