FDA 510(k) Clearance and Progress
HeartBeam received foundational FDA 510(k) clearance for its system, including arrhythmia assessment. They are in positive discussions with the FDA for the 12-lead synthesis software and anticipate clearance by the end of the year.
VALID-ECG Study Success
The VALID-ECG study met its endpoint, supporting the FDA submission for the 12-lead synthesis software. The study showed a 93.4% agreement with standard 12-lead ECGs, demonstrating the effectiveness of HeartBeam's technology.
AccurKardia Collaboration
HeartBeam announced a strategic collaboration with AccurKardia to integrate FDA-cleared ECG algorithms, enhancing their commercial product and reducing time and expenses associated with developing their own solution.
Intellectual Property Expansion
HeartBeam has added two new issued U.S. patents, bringing the total to 20 worldwide, strengthening their proprietary technology position.
Commercial Readiness and Early Access Program
HeartBeam is progressing well towards commercial readiness, including testing with concierge accounts and patients, and has established a contract manufacturer for scaling.
Successful Fundraising
HeartBeam completed an $11.5 million common stock public offering, supporting their strategic funding approach and commercialization efforts.