Anumana is a company that is harnessing industry-leading AI and translational science to decode electrical signals from the heart as never before, empowering healthcare providers to transform patient care throughout the cardiac clinical pathway. Pulse 2.0 interviewed Anumana CEO Maulik Nanavaty to learn more about the company.
Maulik Nanavaty’s Background
Could you tell me more about your background? Nanavaty said:
“I have spent more than 30 years in the healthcare and medical device industry, dedicated to improving patient outcomes through innovation. My career began at Baxter International, where I gained a strong foundation in navigating the complexities of global healthcare systems through leadership roles in medical devices, pharma, and biologics. I then spent nearly 17 years at Boston Scientific, working in interventional cardiology and neuromodulation, as well as serving as Country Head for Boston Scientific Japan.”
“Now, as CEO of Anumana, I have the privilege of leading a company at the forefront of AI-driven innovation in cardiology. Our technology unlocks hidden signals within the standard electrocardiogram (ECG)—one of the most widely used tools in medicine—to improve patient outcomes through earlier detection of heart diseases.”
“What drew me to Anumana was the opportunity to combine my experience in medical technology with the rapid advancements in AI. Our mission is to empower clinicians with cutting-edge tools that streamline decision-making, expand access to innovation, and ultimately improve patient outcomes.”
Formation Of The Company
How did the idea for the company come together? Nanavaty shared:
“Anumana was founded through a partnership between Mayo Clinic and nference—a health technology company leveraging AI to transform biomedical data into actionable insights, merging deep clinical expertise with advanced AI capabilities. nference pioneered AI solutions that extract novel insights from complex healthcare datasets, creating a strong foundation for Anumana.”
“The inspiration came from a key insight from Mayo Clinic—standard 12-lead ECGs, performed over 100 million times annually in the U.S., contain far more clinically relevant information than traditional interpretation methods. The question was: Could AI unlock these hidden signals to detect diseases earlier than traditional approaches? From day one, our focus has been to use deep learning AI to tackle the most pressing challenges across the field of cardiology and make a tangible impact on patient care.”
Core Products
What are the company’s core products and features? Nanavaty explained:
“Our technology seamlessly integrates into clinical workflows without requiring clinicians to change their processes or adopt new hardware. By embedding AI-powered insights directly into the standard ECG workflow, we ensure that our technology is both accessible and easy to use, allowing for real-time analysis without disruption.”
“Anumana develops clinically validated AI algorithms that analyze all data from the standard 12-lead ECG and detect patterns not visible with conventional methods, yet crucial for early disease detection and better outcomes. Our first FDA-cleared algorithm, ECG-AI™ LEF (low ejection fraction), helps detect early signs of heart failure by identifying these hidden indicators. The algorithm was developed and trained using over 100,000 ECG and echocardiogram (Echo) data pairs from unique patients, and clinically validated in a first-of-its-kind multi-site, retrospective clinical study of 16,000 racially diverse patients. The study showed an area under the curve (AUC) of 0.95, demonstrating high accuracy in distinguishing between patients with LEF and those without. A perfect test has an AUC of 1.0, while an AUC of 0.90 or higher is considered excellent performance. For comparison, other commonly used cardiology tests, like the treadmill test and the NT-proBNP blood test for heart failure, typically have AUCs in the 0.7 to 0.8 range.”
“The potential for positive clinical impact using ECG-AI was reinforced in the EAGLE study, a prospective, randomized, controlled clinical trial involving 22,641 adults across 120 primary care teams. The algorithm improved clinicians’ ability to diagnose LEF by 31% compared to the standard of care without increasing overall Echo usage. Such powerful study results can guide clinicians in improving Echo usage for the right patients.”
“ECG-AI LEF is just the beginning. We have a suite of AI-driven algorithms in development, including four with FDA Breakthrough Device Designation, targeting a range of cardiovascular diseases. Our goal is a future where a simple ECG provides life-saving insights for multiple conditions at the point of care.”
Challenges Faced
What challenges has Nanavaty and the team faced in building the company? Nanavaty acknowledged:
“Scaling AI technology for widespread adoption remains a challenge. AI in cardiology is still relatively nascent, and stakeholders—including clinicians, regulators, and payers—are welcoming such new approaches while balancing them against current clinical workflows.”
“Collaboration has been key. A prime example is our direct engagement initiative with CMS and other stakeholders to secure CPT codes in 2023 and a payment rate of $128.90 for our ECG-AI LEF algorithm, effective in January 2025. Reimbursement is a critical step toward widespread adoption. Without it, even the most advanced AI solutions face challenges in scaling. Support from government agencies like CMS and the FDA has validated our approach, helping drive real-world implementation and ensuring that AI-powered cardiac diagnostics reach more patients.”
Evolution Of The Company’s Technology
How has the company’s technology evolved since its launch? Nanavaty noted:
“Anumana has remained deeply committed to large, diverse, well-documented longitudinal datasets. We continue to expand our access to additional data, update our deep learning AI models, and build strength around foundational clinical research that represents everyday clinical practice. Our commitment to these foundational building blocks is allowing us to have confidence in rigorous data analysis and clinical validation that provides robustness in everyday clinical settings. This ensures our deep learning AI models are trained to represent diverse patient conditions and expansive populations while delivering real-world impact, helping provide trust and confidence among clinicians. Significant Milestones
What have been some of the company’s most significant milestones? Nanavaty cited:
- FDA Breakthrough Device Designation for four algorithms: ECG-AI LEF, pulmonary hypertension, cardiac amyloidosis, and hyperkalemia; recognition for our technology’s potential to address critical unmet needs in cardiology.
- FDA clearance for our ECG-AI LEF algorithm: Validated the safety and efficacy of our AI-powered ECG analysis for early heart failure detection; paved the way for Anumana to transition the technology from an investigational tool to a commercially available solution for clinicians.
- Category III CPT codes (0764T and 0765T) in 2023 and Hospital Outpatient Prospective Payment System (OPPS) reimbursement approval from CMS (effective January 2025): Simplifies billing and reimbursement, making it easier for hospitals and clinics to integrate and adopt our AI technology.
- Commercial deployment of ECG-AI LEF algorithm in 2025: Enabled commercial access to the most advanced technology for clinicians.
Each of these milestones reinforces our deep commitment to innovation in AI-driven cardiology solutions for clinicians and patients.”
Customer Success Stories
When asking Nanavaty about customer success stories, he highlighted:
“We are very early in our customer experience; however, early adopters are providing excellent insights and feedback. Additionally, we are receiving significant inbound requests for point-of-care solutions for patients. By integrating AI-driven ECG analysis into routine care, clinicians can detect heart failure earlier, enabling timely intervention and preventing costly late-stage treatments. This shifts care from reactive to proactive, improving patient outcomes while reducing healthcare costs.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Nanavaty assessed:
“The TAM for AI-driven ECG analysis is substantial, with over 300 million standard 12-lead ECGs performed globally each year, including more than 100 million in the U.S. alone. This represents a multi-billion-dollar opportunity across hospitals, clinics, primary care, and remote monitoring settings. By integrating AI technology into existing workflows, we have the opportunity to address a massive market and significantly impact global healthcare outcomes.”
Differentiation From The Competition
What differentiates the company from its competition? Nanavaty affirmed:
“Anumana’s AI algorithms are built on an extensive proprietary dataset, drawing from over 25 million longitudinal patient data from leading institutions like Mayo Clinic, Duke, Emory, Vanderbilt, and Banner. Additionally, the algorithms have been trained on more than 100,000 paired ECGs and Echos.”
“This depth of data ensures our models are highly accurate and reflective of diverse patient populations. Our technology is backed by rigorous clinical validation, with over 75 peer-reviewed publications and multiple retrospective and prospective studies, which demonstrated improved diagnostic accuracy without increasing healthcare utilization. This commitment to high-quality data and evidence-based validation sets Anumana apart as a leader in AI-driven cardiac care.”
Future Company Goals
What are some of the company’s future goals? Nanavaty emphasized:
“We aim to expand our AI solutions into more care settings and develop new algorithms to address additional cardiovascular conditions. In the long term, we seek to redefine how AI integrates into routine healthcare and set new standards for early disease detection and patient outcomes.”
Additional Thoughts
Any other topics you would like to discuss? Nanavaty concluded:
“Anumana is pioneering AI-driven advancements in cardiology with a singular focus on improving patient outcomes. In a short time, we have accelerated clinical research, published peer-reviewed studies, and increased awareness in the field.”
“Our commitment lies in seamlessly integrating AI into clinical workflows, empowering physicians to make timely, informed decisions. This is made possible by our vast institutional network and access to millions of diverse patient data points spanning decades. Our goal is to be a trusted partner to physicians, helping them deliver the best possible care.”
