Anumana Demonstrates Global Readiness with Receipt of ISO 13485 Certification
May 21 2024 - 7:05AM
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-AITM 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
- 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.
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Sam Choinski Pazanga Health Communications for Anumana
schoinski@pazangahealth.com (860) 301-5058