BodyGuardian Remote Monitoring System (BGRMS v3.0)

K243349

Boston Scientific Cardiac Diagnostic Technologies, Inc. · cleared 2026-01-23 · product code DSI · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The BodyGuardian Remote Monitoring System (BGRMS) is a system for recording and analyzing ECG data for cardiac arrhythmias to assist healthcare professionals... Components in the system external to the software include ECG monitors, electrodes, mobile phones and apps... PatientCare - server software responsible for receiving, storing, analyzing, and displaying and reporting data gathered from the ECG monitors; includes the ECG analysis algorithm BeatLogic™™ Al-Based Device Software Functionality (AI-DSF) – Automated classification of continuous ECG based on the proprietary BeatLogic™™ Al algorithm.”
Algorithmensemble of deep neural networks (DNNs), trained on real-world patient data and post-processing logic that combines the DNN output to produce individual beat, rhythm, and waveform classifications
source quote (p.7)
“BeatLogic consists of an ensemble of deep neural networks (DNNs), trained on real-world patient data and post-processing logic that combines the DNN output to produce individual beat, rhythm, and waveform classifications.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“Cybersecurity Testing”

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: Sensitivity; Positive Predictive value (PPV)

standards: EC57

Reported performance (1 observation)

ppvas written: “Positive Predictive value (PPV)”stated without value
source quote (p.9)
“Performance of the algorithm was assessed by evaluating the Sensitivity and Positive Predictive value (PPV) for key rhythms across different patient subgroups.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

21
recalls in product code, 24mo
373
MAUDE reports in code, 12mo
-74%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DSI (GE Medical Systems Information Technologies Inc, initiated 2025-04-25): "The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially mani" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96830

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243349