iCAD, Inc. announces 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, an AI software for digital breast tomosynthesis (DBT) that netted U.S. FDA clearance in 2018.

“It is a significant accomplishment for our technology to achieve this authorization,” says Stacey Stevens, president and incoming CEO 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.”

The DoD’s Risk Management Framework (RMF) requires technologies be granted an ATO 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 cyberattack. 

There are currently more than 500 DoD hospitals, inpatient facilities, ambulatory care, and occupational health facilities worldwide. 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.

ProFound AI is a cancer detection technology that analyzes each tomosynthesis image, detecting both malignant soft tissue densities and calcifications. Built with deep-learning AI technology, the software assists radiologists by 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% improvement in average reader sensitivity and a 7% improvement in average reader specificity. Furthermore, the technology reduced reading time for radiologists by 52.7%.

“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,” adds Stevens. “With one in eight women at risk of being diagnosed with breast cancer in their lifetime, 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.”