Jewel patch defibrillator ended eight of nine life-threatening rhythms

In a study at 29 US sites that FDA reviewed, the Jewel patch defibrillator gave 0.357 inappropriate shocks per 100 patient-months. It converted 8 of 9 shockable rhythms with one shock.

  • 4 a person

    Eight patients had a life-threatening ventricular rhythm ended by a single shock from the device.

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

Pre-specified performance goal for inappropriate shocks. Measured.

Without the system
Below 2.0 per 100 patient-months
With it
0.357 per 100 patient-months
The system’s part
Not isolated. The study had no control group and did not compare the machine learning detector with another detector or with no device. FDA reviewers compared the rate of inappropriate shocks with a performance goal.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

Download data Cite Suggest a correction

Benefit type
Improved Physical Health
System
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) with a machine learning VT/VF detection algorithm
Made by
Element Science, Inc.
Used by
Twenty-nine US investigational sites in the Jewel IDE study
Where
Twenty-nine investigational sites, United States
Stage
In a pilot
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. Summary of Safety and Effectiveness Data (SSED), P230022: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD). Approved 2025-04-30.

    The inappropriate shock rate was calculated to be 0.357 shocks per 100 patient-months, with an upper 98% confidence interval of 1.526, meeting the primary effectiveness endpoint successfully. A total of 9 appropriate shock events were observed with 8 successful single-shock conversions.

Details

AI system

Workflow

Patients wore the patch for an average of 21.3 hours a day and replaced the patches every eight days or sooner. The detector classified segments of ECG and started an alarm after several shockable segments in a row.

Follow-up

Conditions for replication

The patient is 18 or older, at risk of sudden cardiac arrest and without an active implantable defibrillator. The patient keeps wearing the device through the prescribed period.

Entry details

Sector

Healthcare.

Purpose

Element Science built the Jewel to detect life-threatening ventricular tachycardia or fibrillation in people at risk of sudden cardiac arrest and shock the heart back to an organized rhythm.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, 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). Jewel patch defibrillator ended eight of nine life-threatening rhythms (AIBD-0789). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0789.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

BibTeX Data Field definitions