Opioid Halo cut non-actionable alarms in opioid overdose monitoring

In data that FDA reviewed, Opioid Halo caught opioid-induced respiratory depression as reliably as an oximeter alarm with a fixed threshold. It raised up to 96.7% fewer non-actionable alarms.

  • Not rated a person

    The comparison ran on recorded data, and FDA credits no rescue to the device's alarms.

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

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

A pulse oximeter alarm with a fixed threshold, run on the same data. Measured.

Without the system
33415 alarms from the fixed-threshold benchmark in 936 people
With it
3663 alarms at Level 2 and 1097 at Level 3
The system’s part
Opioid Halo and an oximeter alarm with a fixed threshold were compared on the same data, so the gain in specificity is attributed to the software. The decision summary does not show that Opioid Halo learns from data, since FDA describes it as detecting patterns in oxygenation data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
Masimo SafetyNet Opioid System (Opioid Halo software)
Made by
Masimo Corporation
Used by
Masimo (clinical validation on 40,322 data segments from 641 opioid users)
Where
Sites not stated in the decision summary (prescription home, hospital and illicit opioid users)
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Monitoring Processes, Materials, or Surroundings, Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
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 Masimo SafetyNet Opioid System (DEN200011): decision summary. Granted 2023-03-31.

    The analysis found equivalent sensitivity as a system with a higher specificity in the detection of OIRD as compared to a pulse oximeter with a fixed threshold alarm.

Details

AI system

Workflow

A finger sensor fed oxygen saturation, pulse rate and perfusion index to the software. Alarms escalated from the user to emergency contacts and then to emergency dispatch.

Follow-up

Conditions for replication

The user is 15 or older and is on no more than 2.0 L/min of supplemental oxygen. Use is supervised by people aware of countermeasures such as naloxone.

Entry details

Sector

Healthcare.

Purpose

Masimo built the SafetyNet Opioid System to monitor people using opioids at home or in hospital and alarm when their oxygenation shows signs of opioid-induced respiratory depression.

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). Opioid Halo cut non-actionable alarms in opioid overdose monitoring (AIBD-0777). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0777.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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