PMD-200 guidance lowered pain scores after abdominal surgery

In two randomized trials that FDA reviewed, dosing fentanyl by the PMD-200's NOL index lowered pain scores after abdominal surgery by 30-33% against standard care.

  • 2 a person

    Patients whose fentanyl was dosed by the index had median pain scores in recovery 1.6 points lower in one trial and 1.5 points lower in the other.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Standard fentanyl dosing guided by blood pressure and heart rate in the randomized control groups. Measured.

Without the system
Median pain score 5 after 60 minutes in recovery (Abdomi-NOL)
With it
Median pain score 3 after 60 minutes in recovery (Abdomi-NOL)
The system’s part
Patients in both trials were randomized to fentanyl dosing guided by the index or to standard dosing. The index was hidden from the control team, so the trials isolate its contribution. FDA reviewers write that the algorithm was trained on recordings kept apart from the validation data. The learning method is not named.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Physical Health
System
PMD-200 with the Nociception Level (NOL) index
Made by
Medasense Biometrics Ltd.
Used by
Leiden University Medical Center and Alrijne Hospital (SOLAR trial) and Shaare Zedek Medical Center (Abdomi-NOL trial)
Where
Leiden and Leiderdorp, Netherlands, and Jerusalem, Israel
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Monitoring Processes, Materials, or Surroundings, Estimating the Quantifiable Characteristics of Products, Events, or Information
Collections
Scrutiny and findings, Cross-border records
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo Classification Request for PMD-200 (NOL index) (DEN210022): decision summary. Granted 2023-02-17.

    These reductions represent 30-33% improvement on the 11-point NRS scale in comparison to the standard of care control groups.

Details

AI system

Workflow

Investigators received instructions, set before enrollment, on how to dose fentanyl from the index. Patients had major abdominal surgery under sevoflurane anesthesia with fentanyl boluses. In the control group the device was connected but hidden from the anesthesia team.

Follow-up

Conditions for replication

The patient is an adult under general anesthesia who receives opioid or opioid-sparing analgesia. Clinicians read the index together with other clinical and vital signs.

Entry details

Sector

Healthcare.

Purpose

Medasense built the PMD-200 to measure the response of patients under general anesthesia to painful stimuli and help clinicians tailor pain medication to it.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). PMD-200 guidance lowered pain scores after abdominal surgery (AIBD-0779). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0779.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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