EchoNext
Pathwai, Inc. · 510(k) · K260332
Last verified Oct 22, 2026
Identity
Regulatory
- Regulatory pathway
- 510(k)1
Source passage
2026-06-08,K260332,EchoNext,Pathwai, Inc.,Cardiovascular,QXO
- Submission number
- K2603321
Source passage
2026-06-08,K260332,EchoNext,Pathwai, Inc.,Cardiovascular,QXO
- Decision date
- 2026-06-081
Source passage
2026-06-08,K260332,EchoNext,Pathwai, Inc.,Cardiovascular,QXO
- Product code
- QXO1
Source passage
2026-06-08,K260332,EchoNext,Pathwai, Inc.,Cardiovascular,QXO
- Lead review panel
- Cardiovascular1
Source passage
2026-06-08,K260332,EchoNext,Pathwai, Inc.,Cardiovascular,QXO
- Predicate device
- Viz HCM (DEN230003)2
Source passage
Predicate Device Trade / Device Name: Viz HCM (DEN230003)
- Predetermined change control plan
- not stated
- Other jurisdictions
- not stated
Intended use
- Intended use
- EchoNext is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG (electrocardiogram) made on compatible ECG devices.1
Source passage
EchoNext is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG (electrocardiogram) made on compatible ECG devices.
- Indications for use
- 12-lead ECG recordings collected from patients 18 years of age or older.1
Source passage
EchoNext is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older.
Clinical domain and care pathway
- Clinical domain
- ECG1
Source passage
EchoNext is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG (electrocardiogram) made on compatible ECG devices.
- Care pathway steps
- Detection, Triage1
Source passage
EchoNext is capable of analyzing the ECG, detecting signs associated with structural heart disease (SHD)... EchoNext identifies patients for further SHD follow-up and is not intended to replace the current standard of care methods for diagnosis of SHD.
- Conditions
- Structural Heart Disease (SHD), Left Ventricular Ejection Fraction (LVEF) dysfunction, Left Ventricular Hypertrophy (LVH), Aortic Stenosis (AS), Valvular Regurgitation, Right Ventricular Ejection Fraction (RVEF) dysfunction, Pulmonary Hypertension (PH)1
Source passage
SHD: Structural Heart Disease LVEF: Left Ventricular Ejection Fraction LVH: Left Ventricular Hypertrophy AS: Aortic Stenosis Valvular Regurgitation RVEF: Right Ventricular Ejection Fraction PH: Pulmonary Hypertension
Function
- Input data
- 12-lead ECG waveform data, basic demographic inputs1
Source passage
The device evaluates ECG waveform data in combination with basic demographic inputs to generate a notification indicating whether the ECG demonstrates patterns associated with suspicion of structural heart disease.
- Output
- Binary notification indicating whether the ECG demonstrates patterns associated with suspicion of structural heart disease, and potential sub-labels for affected cardiac structures.1
Source passage
generate a notification indicating whether the ECG demonstrates patterns associated with suspicion of structural heart disease. When SHD is suspected, the device may also provide informational indicators corresponding to affected cardiac structures.
- Autonomy
- Detection1
Source passage
EchoNext is capable of analyzing the ECG, detecting signs associated with structural heart disease (SHD), and allowing the user to view the ECG and analysis results.
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Integration
- PACS integration
- not stated
- EHR integration
- not stated
- Deployment
- not stated
- Workflow notes
- not stated
Published literature
- Transportability of an artificial intelligence electrocardiography model for structural heart disease: external validation and recalibration of EchoNext-Mini in MIMIC-IV. European heart journal. Digital health, 2026
Change log
- Version 1, published Oct 22, 2026