Leading-edge breast cancer detection platform meets stringent U.S. government security thresholds required for use across military healthcare facilities
iCAD, Inc.a global medical technology leader providing innovative cancer detection and therapy solutions, announced that the Company’s breast artificial intelligence (AI) platform was granted an Authorization to Operate (ATO) from the U.S. Department of Defense (DoD). iCAD’s breast AI platform includes ProFound AI®, which became the first AI software for digital breast tomosynthesis (DBT) to be FDA cleared in 2018.
“It is a significant accomplishment for our technology to achieve this authorization,” said Stacey Stevens, President and incoming Chief Executive Officer of iCAD, Inc. “This distinction is a testament to the security of our technology and reinforces our steadfast commitment to providing safe and reliable health solutions to our customers and their patients. We look forward to capitalizing on this new market opportunity and continuing to expand access to ProFound AI and enhancing patient care for those in the military and their families.”
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The DoD’s Risk Management Framework (RMF) requires technologies be granted an ATO in order to be approved for use at a DoD healthcare facility. Earning an ATO distinction requires the technology to meet the DoD’s stringent cybersecurity prevention thresholds, which are designed to minimize the risk of a potential cyber-attack. There are currently more than 500 DoD hospitals, inpatient facilities, ambulatory care and occupational health facilities worldwide.i The Military Health System (MHS) offers healthcare benefits and services through its TRICARE program to approximately 9.62 million beneficiaries, including servicemembers, military retirees, and family members.ii
ProFound AI is a high-performing cancer detection solution that rapidly and accurately analyzes each tomosynthesis image, detecting both malignant soft tissue densities and calcifications. Built with the latest in deep-learning AI technology, the software is clinically proven to assist radiologists by improving cancer detection and reducing reading times, while lowering false positive rates and unnecessary recalls. Used concurrently when reading mammography exams, Profound AI’s algorithm produces Certainty of Finding lesion and Case Scores, which represent the algorithm’s confidence that a detection or case is malignant. According to a large reader study, Profound AI for DBT achieved an 8 percent improvement in average reader sensitivity and a 7 percent improvement in average reader specificity. iii Furthermore, the technology reduced reading time for radiologists by 52.7 percent.iii
“ProFound AI is unrivaled in its accuracy, performance, and speed, and is truly transforming breast cancer screening and detection by enhancing both the patient and radiologist experience,” added Stevens. “With one in eight women at risk of being diagnosed with breast cancer in their lifetimeiv, the need for accurate and secure technology like ProFound AI could not be more important to help doctors catch the disease earlier and, ultimately, improve health outcomes for patients.”
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