Michael Barbella, Managing Editor06.21.24
Anumana has achieved International Organization for Standardization (ISO) 13485 certification for its Quality Management System. This certification indicates that a company has developed robust policies and procedures for developing and manufacturing regulated medical devices.
Anumana received ISO 13485 certification after 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,” Anumana Chief Business Officer David McMullin said. “As an international medical device manufacturer, this milestone underscores our leadership in 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 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. Food and Drug Administration clearance last fall and is currently under review in Europe.
Anumana leverages cutting-edge AI and translational science to unlock the heart's electrical language. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations and develop ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool. Anumana’s software-as-a-medical device (SaMD) ECG-AI solutions aim to detect hidden diseases using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.
Reference
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.
Anumana received ISO 13485 certification after 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,” Anumana Chief Business Officer David McMullin said. “As an international medical device manufacturer, this milestone underscores our leadership in 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 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. Food and Drug Administration clearance last fall and is currently under review in Europe.
Anumana leverages cutting-edge AI and translational science to unlock the heart's electrical language. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations and develop ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool. Anumana’s software-as-a-medical device (SaMD) ECG-AI solutions aim to detect hidden diseases using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.
Reference
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.