Anumana Demonstrates Global Readiness with Receipt of ISO 13485 Certification

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Anumana, a leading AI-driven health technology company and portfolio company of nference, announced today that it has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System. This certification, the quality management standard for device manufacturers, indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical devices.

Anumana received ISO 13485 certification following an independent third-party certification firm’s rigorous assessment of its Quality Management System. With this certification, Anumana strengthens its ability to provide software-as-a-medical device (SaMD) ECG-AI™ algorithms that consistently meet customer and regulatory requirements.

“Anumana’s ISO13485 certification is a testament to our commitment to excellence in the development and manufacturing of regulated medical devices that adhere to international standards and requirements,” said David McMullin, Anumana’s chief business officer. “As a rapidly growing international medical device manufacturer, this milestone underscores our leadership in pioneering and bringing to market clinically validated and regulated ECG-AI™ algorithms as SaMDs, validates our capabilities, and enables Anumana to extend the reach of our technology to clinicians and patients worldwide.”

ECG-AI™ LEF, the company’s FDA-cleared, breakthrough AI algorithm using routine 12-lead ECG data to detect Low Ejection Fraction (LEF), a commonly undiagnosed indicator of heart failure,¹ received U.S. FDA clearance in September 2023 and is currently under review in Europe.

About Anumana

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI^TM solutions aim to detect hidden diseases using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.

Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF.

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022 and received the 2024 Medtech Breakthrough award for Best New Technology Solution, cardiology. Follow Anumana at anumana.ai and on LinkedIn and Twitter.

References

1. Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.