Cardiovascular · 510(k) · 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc.. Cleared by FDA on 23 January 2026 under submission K243349, product code DSI (detector and alarm, arrhythmia). What FDA's record says, in FDA's words.
Device record · K243349
- Device. BodyGuardian Remote Monitoring System (BGRMS v3.0)DEVICE
- Company. Boston Scientific Cardiac Diagnostic Technologies, Inc.COMPANY
- Decision. 23 January 2026, 510(k), substantially equivalent (traditional review); received 28 October 2024DECISION
- Panel. CardiovascularPANEL
- Product code. DSI, Detector And Alarm, ArrhythmiaCODE
- Regulation. 21 CFR 870.1025, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The BodyGuardian Remote Monitoring System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients who are at least 29 days old in clinical and non-clinical settings to collect and transmit electrocardiogram (ECG) and other health parameters to healthcare professionals for monitoring and evaluation. Health parameters, such as heart rate and ECG data, are collected from external devices such as ECG sensors. The BodyGuardian Remote Monitoring System does not provide any diagnosis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 33,431 reports filed against devices carrying product code DSI. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Reveal LINQ · Medtronic Europe Sarl · report 9614453-2026-03925
It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing on Bradycardia and Atrial Tachycardia (AT)/ Atrial Fibrillation (AF) episodes. It was noted that the remote monitoring report failed to generate and was not received for review. The ICM remains in the patient. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · IntelliVue MX40 1.4GHz · Philips Medical Systems · report 1218950-2026-100678
It was reported the device was presented with a speaker malfunction error message and it is unknown if there was still sound. The device was not in clinical use. There was no report of patient or user harm.
30 September 2026 · Injury · Medtronic ILR · Medtronic, Inc. · report 2182208-2026-55650
Literature was reviewed regarding Implantable Cardiac Monitors (ICMs). The authors described a patient who experienced an infection approximately seventeen days post implant of the ICM. The device was explanted and replaced. The status of the device is unknown. No additional adverse patient effects were reported.
29 September 2026 · Malfunction · ECG Electrodes · Philips Medical Systems · report 1218950-2026-100672
Philips received a complaint on a CBL ECG 5 lead Grabber AAMI + SpO2, Tele indicating the lead set was not working and was unable to provide appropriate rhythm; the readings were inaccurate. The device was in clinical use at the time the issue was discovered. There was no adverse or patient harm reported.
29 September 2026 · Malfunction · ECG Electrodes · Philips Medical Systems · report 1218950-2026-100676
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DSI, in Cardiovascular, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.