Curemetrix Secures ANVISA Registration Approval In Brazil For Cmangio®, Detecting Breast Arterial Calcifications


(MENAFN- EIN Presswire)

The Artificial Intelligence (AI)--based deep learning algorithm helps radiologists identify breast arterial calcifications (BAC) in screening mammograms.

SAN DIEGO, CA, UNITED STATES, March 14, 2024 /EINPresswire / -- CureMetrix, a global leader in AI-driven medical imaging solutions, proudly announces the successful registration approval of its innovative product, cmAngio® , by the National Health Surveillance Agency (ANVISA) in Brazil. cmAngio is an Artificial Intelligence (AI) based Software as a Medical Device (SaMD). The device is designed to detect Breast Arterial Calcifications (BAC), a type of medial vascular calcification that is indicative of arteriosclerosis.

cmAngio analyzes both full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms to identify and mark these anomalies which are currently only identified as incidental findings. Importantly, cmAngio allows radiologists to use existing screening mammograms to identify women who have BAC and as appropriate refer them for additional evaluation tied to heart health outcomes.

”CureMetrix proudly celebrates the registration approval of cmAngio by ANVISA in Brazil, marking a significant achievement in our ongoing commitment to advancing women's health globally.” According to Kevin Harris, President at CureMetrix.“The ability of cmAngio to detect Breast Arterial Calcifications is a new innovative capability in mammography delivering important information to women and their doctors. The ANVISA registration approval reflects our global focus on market-leading solutions that address critical challenges in healthcare. We are excited about the positive impact cmAngio will have on patient outcomes and are dedicated to collaborating with healthcare institutions to ensure its widespread adoption."

Among women who have had screening mammograms, the prevalence of BAC varies from around 12 to 42.5% (source 1). However, less than 5% of all instances of incidental findings of BAC in mammograms are reported (source 2). With this prevalence rate, CureMetrix focused on high specificity to reduce false positives and an adjustable operating point that meets the clinical goals of a healthcare facility.

"The established link between BAC and potential heart outcomes in published literature underscores the significance of this milestone in women's health globally. As a cardiologist, I believe cmAngio's registration approval by ANVISA in Brazil, coupled with its seamless integration into mammography screening, heralds a new era in the ability to detect and assess Breast Arterial Calcifications. CureMetrix's commitment to advancing women's health is evident, and I look forward to collaborating with healthcare professionals to ensure widespread adoption and a positive impact on patient outcomes." said, Dr. Nitesh Nerlekar, MD, Director of Clinical Research, Cardiology at CureMetrix.

cmAngio is poised to transform the healthcare landscape, providing healthcare professionals with a powerful tool to further assess Breast Arterial Calcifications and the information they present to women and their doctors. CureMetrix looks forward to collaborating with healthcare institutions, radiologists, and medical professionals across Brazil to ensure the widespread adoption of this cutting-edge technology.

CureMetrix has also received registration approval from ANVISA in Brazil for its products, cmTriage® and cmAssist® . cmTriage is software designed to assign a notification triage code to the radiologist's mammography worklist, indicating the presence of a suspicious region of interest identified by the underlying algorithm. This workflow optimization tool allows radiologists to tailor their 2D mammogram or mammography worklist based on cases requiring immediate attention. cmAssist is a computer-aided detection (CAD) software utilizing artificial intelligence (AI) to assist radiologists in identifying, marking, and scoring regions of interest in screening mammograms.

For more information about CureMetrix and cmAngio, please visit .

Indications may vary for regions. Please consult the company for specific geographies.

Sources
1
2 Internal CureMetrix analysis of 346,000 mammograms collected from 2008-2018

Brock Anderson
CureMetrix
+1 858-333-5830
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