Partnership Overview
HeartBeam, a company specializing in cardiac medical technology, has partnered with AccurKardia, known for its ECG diagnostics software platform. This collaboration aims to integrate AccurKardia’s ECG analysis software into HeartBeam’s innovative devices.
Key Features of HeartBeam’s Technology
- HeartBeam’s system is a cable-free, 12-lead ECG that captures heart electrical signals from three different angles.
- The technology is designed for portability, allowing physicians to monitor cardiac health trends and acute conditions in various settings.
Regulatory Progress
In January, HeartBeam submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, which evaluates various heart rhythms and conditions, including:
- Sinus rhythm
- Atrial fibrillation
- Atrial flutter
- Bradycardia
- Tachycardia
- Premature ventricular contraction
- Premature atrial contraction
Benefits of the Collaboration
The integration of AccurKardia’s automated ECG interpretation platform into HeartBeam’s devices is expected to:
- Provide earlier and more accurate management of heart health.
- Enhance accessibility to cardiac monitoring solutions.
Statements from Leadership
Robert Eno, CEO of HeartBeam, stated, “This collaboration is a significant advancement in making remote cardiac monitoring more accessible and scalable.” He emphasized the shared mission of both companies to improve cardiac outcomes through innovation.
Juan C. Jimenez, CEO of AccurKardia, added, “Combining our strengths will create a best-in-class platform that empowers patients to manage their cardiac health effectively.”
Industry Context
In February, HeartBeam announced a public offering of 5.8 million shares at $1.70 each, aiming for gross proceeds of $10 million to support various initiatives, including:
- Commercial readiness
- Research and development
- Clinical and regulatory projects
- Working capital
Additionally, AccurKardia received FDA Breakthrough Device Designation for its AI-powered AK+ Guard software, which detects hyperkalemia, a condition that can lead to sudden cardiac arrest.
In 2024, AccurKardia’s Aortic Valve Stenosis ECG-based AI screening software also received FDA Breakthrough Device Designation, further highlighting the advancements in cardiac diagnostics.