CureMetrix Receives ISO 13485:2016 Certification for Artificial Intelligence (AI)-Based Mammography Software


Achieving quality management system certification is helping the health technology company bring its AI-powered digital mammography solutions to market globally.

The ISO 13485:2016 certification process aligns with our strategic goal of bringing quality solutions to market to strengthen women’s health.”

—Kevin Harris, President of CureMetrix

SAN DIEGO, CA, USA, Aug. 2, 2022 / — CureMetrix®, a global health technology company that develops AI-based software for radiology, today announced that it has received ISO 13485:2016 certification for quality management systems (QMS). This certification helps the company bring its advanced AI-powered digital mammography solutions to more doctors and patients around the world.

“The ISO 13485:2016 certification process aligns with our strategic goal of bringing quality solutions to market to strengthen women’s health,” said Kevin Harris, president of CureMetrix. “We are extremely proud of this milestone by our passionate team that furthers the company’s excellence in software as a medical device (SaMD) to help improve outcomes for patients and providers.”

ISO 13485:2016 is a globally recognized quality and safety standard for the medical device industry. It provides a strategic framework for adhering to medical device guidelines and regulations to ensure an effective, robust and continuously improving quality management system.

The scope of the ISO 13485:2016 certification awarded to CureMetrix covers the design and development of software for digital mammography systems. CureMetrix AI-powered solutions for mammography include:

cmTriage® is the first FDA-approved software to provide a notification triage code to the radiologist’s mammography worklist based on the presence of a suspicious region of interest detected by the underlying algorithm. This workflow optimization tool allows a radiologist to customize their mammography worklist based on cases that may need immediate attention.

cmAssist® is experimental computer-aided detection (CAD) software that leverages AI to help radiologists identify, mark, and score regions of interest on screening mammograms.

cmDensity™ is AI-based software that helps radiologists classify and report breast density accurately and consistently, reducing inter- and intra-reader variability.

cmAngio® is experimental AI-based software that helps doctors assess a patient’s age-adjusted heart disease risk. cmAngio produces a CureMetrix Bradley Score™ based on the existence and characteristics of breast artery calcifications in mammography. This proprietary score can then be used to help the healthcare team assess the patient’s age-adjusted percentage of breast artery calcifications in her mammogram that were found to be associated with coronary artery disease. The Bradley Score can be tracked over time to help patients and physicians understand changes in their health profile.

“Our team is dedicated to helping physicians streamline their workflow, improve patient outcomes, reduce healthcare costs, and better screen and detect disease earlier,” Harris continued. “Using the power of AI for medical imaging to read mammograms allows radiologists to perform at their best and impact the lives of more patients.”

To learn more about CureMetrix solutions, please visit

About CureMetrix

CureMetrix is ​​a global leader in artificial intelligence for medical imaging, committed to advancing technology that improves disease detection and cancer survival rates worldwide. Its mission is to help save lives through earlier and more accurate disease detection and to support improved clinical and financial outcomes, by providing technology that radiologists, healthcare systems and patients can rely on. in complete confidence. Visit

Disclaimer: cmTriage® is cleared by the FDA for commercial use in the United States cmTriage® and cmAssist® are cleared ANVISA in Brazil. cmAngio® and cmDensity™ are under development and not available for commercial use in any country.

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