K250258 is an FDA 510(k) clearance for the HeartBeam AIMIGo with 12-L ECG Synthesis Software System. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.
Submitted by Heartbeam, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 8, 2025 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Heartbeam, Inc. devices
NCT06123130
Completed
Interventional
Industry-sponsored
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
| Condition studied |
Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Peter J. Fitzgerald, MD, PhD |
| Sponsor |
HeartBeam, Inc.
(industry)
|
Started 2024-03-13
→
Primary completion 2024-06-20
Primary outcome
Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L
Secondary outcome
Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.
Study completed - no results published.
This trial concluded in 2024 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov