BodyGuardian Remote Monitoring System (BGRMS v3.0)
by Boston Scientific Cardiac Diagnostic Technologies, Inc.
510(k) K243349
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243349 | Date23 Jan 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The BodyGuardian Remote Monitoring System (BGRMS v3.0) is a Detector and Alarm, Arrhythmia device, classified under FDA product code DSI. It is designed to continuously monitor cardiac activity remotely, providing real-time electrocardiogram (ECG) data for diagnostic evaluation of arrhythmias and other cardiac irregularities. The system enables long-term, patient-worn monitoring to support clinical decision-making in cardiovascular care.
This device is supplied as a reusable remote monitoring system intended for use in clinical and home settings. It is not sterile and requires proper calibration and maintenance as specified by the manufacturer. The BGRMS v3.0 has received FDA 510(k) clearance under the Traditional pathway, with a decision date of January 23, 2026. Compliance with regulatory standards ensures its use in cardiovascular diagnostics, though specific MRI safety or single-use attributes are not indicated in the available data.
From the manufacturer
BodyGuardian™ remote cardiac monitor A comfortable, waterproof heart monitor that patients can wear 24/7. A powerful remote ECG device that delivers the data physicians require.
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Questions
AI-generated answers, 20 Sep 2026
What is the BodyGuardian Remote Monitoring System (BGRMS v3.0) primarily used for in clinical practice?
The BGRMS v3.0 is designed for continuous, remote monitoring of cardiac activity, specifically to detect and evaluate arrhythmias and other cardiac irregularities. It provides real-time ECG data, enabling long-term patient monitoring in both clinical and home settings to support clinical decision-making in cardiovascular care.
Is the BodyGuardian Remote Monitoring System (BGRMS v3.0) intended for single-use or reusable applications?
The BGRMS v3.0 is explicitly described as a reusable remote monitoring system. It requires proper calibration and maintenance as outlined by the manufacturer, so it is not intended for single-use.
What regulatory pathway was followed for FDA clearance of the BodyGuardian Remote Monitoring System (BGRMS v3.0)?
The BGRMS v3.0 received FDA clearance under the Traditional 510(k) pathway, with a decision date of January 23, 2026. The device is classified under FDA product code DSI (Detector and Alarm, Arrhythmia) and was reviewed by the Cardiovascular (CV) Advisory Committee.
Does the BodyGuardian Remote Monitoring System (BGRMS v3.0) come in multiple sizes or models, and if so, how are they differentiated?
The provided data includes multiple FEI numbers (Foreign Entity Identification numbers), which typically correspond to different models or configurations of the device. While exact size or model specifications are not detailed, these identifiers suggest the system may offer variations for different clinical or patient needs. For precise details, refer to the manufacturer’s documentation or contact Boston Scientific.
How should the BodyGuardian Remote Monitoring System (BGRMS v3.0) be stored, and is it sterile?
The BGRMS v3.0 is not sterile and requires proper storage as outlined by the manufacturer. Since it is reusable, storage conditions should align with the manufacturer’s guidelines to maintain functionality, calibration, and hygiene standards for repeated use in clinical or home settings.