FDA Cleared AI Systems for Diagnosing Breast Cancer and Brain Bleeding

This past week, two medical-device manufacturers received FDA clearance for artificial intelligence (AI) systems with diagnostic capabilities. These technologies, made by Aidoc and iCAD, couple traditional radiography with AI algorithms to make real-time diagnoses in patients. Adding to the growing number of FDA approvals for AI in medicine, these systems are ushering in a new era of digitalized healthcare.


Aidoc, a Tel-Aviv company based in Israel, received FDA clearance for an AI system that aids radiologists in detecting acute intracranial hemorrhage (ICH) from head computed tomography (CT) scans. The company claims that this is the first deep learning solution available that assists radiologists in clinical triage.

The system immediately examines a CT test after the patient is scanned and flags the evaluation if it detects ICH. In Aidoc’s statement issued August 8,2018, they stress that though the number of radiographs ordered a year is increasing, the number of radiologists available is not keeping up. Dr. Barry D. Pressman, MD, Imaging Chairman at Cedars-Sinai Medical Center, believes that the system’s “seamless integration into the workflow and broad applicability,” makes it a solution to this problem. “In a recent clinical study we ran, Aidoc’s brain package demonstrated its potential to substantially reduce report turnaround time and increase the radiologist’s confidence,” he said.


The second FDA cleared system, made by the New Hampshire based company iCAD, uses AI alongside traditional tomography to assess patients’ breast density. This system, PowerLook Density Assessment Version 3.4, is compatibile with iCAD’s digital breast tomosynthesis and adds to the company’s collection of breast health solutions.

In women with dense breast tissue, the presence of tumors can often be masked in a traditional mammogram. A study published in the Annals of Internal Medicine found that 40-50% of women in the US have dense breasts, which can also increase tumor aggressiveness.

The automated system is described as a fast and reproducible means of delivering assessments of breast density. Dr. Beth Ingram, MD, Radiology at Reid Health, Indiana, states that “we must consider many aspects of each patient’s case at once, but PowerLook Density Assessment allows us to focus on our primary goal of finding breast cancer.”

“Breast density plays a critical role in both risk assessment and accuracy, as mammography sensitivity is reduced to approximately 48 percent from an average of 98 percent in those women with dense breasts,” said Ken Ferry, CEO of iCAD. “Our cutting-edge technology rapidly produces consistent breast density results while reducing the risk of reader variability, enabling radiologists to more easily identify women who might benefit from additional screening.”

Sources: GlobeNewsWire, RadiologyBusiness, PRNewsWire