The latest announcements and milestones from Cardiolytix.
Cardiolytix, Inc. today announced the initiation of its Series B fundraise, targeting $25 million in new capital to accelerate commercial expansion and advance its FDA regulatory pathway. The company is well-capitalized with cash runway extending through 2027, based on current operating projections, and plans to use Series B proceeds to expand its sales organization, fund post-clearance commercial launch, and invest in next-generation algorithm development.
Cardiolytix, Inc. today announced that its CardioScan AI platform has surpassed $12.4 million in annual recurring revenue (ARR), representing approximately 40% year-over-year growth. The milestone reflects accelerating adoption of AI-powered cardiac diagnostics across health systems nationwide and validates the company's land-and-expand commercial strategy.
Cardiolytix, Inc. today announced positive interim results from its Phase 2 multi-center clinical trial of CardioScan AI. The trial achieved 89% sensitivity and 91% specificity in detecting cardiac abnormalities from 12-lead ECG data, exceeding predicate device benchmarks of 76% sensitivity and 85% specificity. The results reinforce CardioScan AI's potential to significantly improve clinical outcomes in cardiac diagnostics.
Cardiolytix, Inc. today announced that Southern Health System, a multi-hospital healthcare network based in Atlanta, Georgia, has selected CardioScan AI for enterprise deployment. The agreement covers all Southern Health cardiac care facilities and includes HL7 FHIR integration with the system's existing electronic health record infrastructure.
Cardiolytix, Inc. today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for CardioScan AI, its AI-powered cardiac diagnostic platform. The submission, filed under Class II medical device classification, represents a major milestone in the company's regulatory pathway and follows completion of ISO 13485 certification and SOC 2 Type I examination.
Cardiolytix, Inc. today announced the filing of its third patent application with the United States Patent and Trademark Office (USPTO), further strengthening the company's intellectual property portfolio. The new application covers Cardiolytix's proprietary machine learning pipeline for multi-lead ECG interpretation, building on the company's existing portfolio of innovative cardiac AI technology.
Cardiolytix, Inc. today announced the closing of an $8 million Series A financing round led by Meridian Ventures, with participation from HealthTech Angels Fund. The proceeds will fund the company's Phase 2 clinical trial, expansion of its engineering team, and initial commercial launch of the CardioScan AI platform.
Dr. Elena Vasquez and Marcus Chen today announced the founding of Cardiolytix, Inc., a Boston-based healthtech company dedicated to improving cardiac diagnostics through artificial intelligence. The company's CardioScan AI platform applies deep learning to 12-lead ECG data to enable earlier detection of cardiovascular disease.
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Rachel Greene
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