AI Oncology Imaging Suite Gains FDA Clearance

Arterys Inc. (San Francisco, CA, USA), a provider of intelligent cloud-based medical imaging software solutions, has received its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arterys Oncology AI suite.

Arterys offers a suite of applications for clinicians on the Arterys network via MICA, its web-based AI platform. MICA enables use and interaction with deep learning algorithms in real-time, augmenting the clinician and expediting image interpretation. The company focuses on reducing variability and subjectivity in the clinical diagnoses, and alleviating the enormous workloads of radiologists.


The new oncology software complements Arterys' existing web-based offering, and helps clinicians measure and track tumors or potential cancers, and easily apply radiological standards. The initial deep learning workflows will be for liver MRI and CT scans as well as for lung CT scans. With this new technology, radiologists can now easily confirm, evaluate, quantify, and report on the absence or presence of lung nodules and liver lesions along with their key characteristics using a simple web browser. The company plans additional deep learning workflows for solid tumors in other organs.

"The evaluation of primary and metastatic disease in the lung and liver are among the most valuable contributions of radiologists to the care of patients with cancer," said radiologist and Arterys co-founder Albert Hsiao. "We desperately need more efficient technology to automatically track lung and liver lesions to further improve diagnosis, assess response to treatment, and automate reporting with standardized terminology including Lung-RADS and LI-RADS. The Oncology Lung AI and Liver AI products are designed to maximize efficiency and accuracy of the radiologist read and will power next-generation radiology interpretation."

"Cancer is one of the leading causes of morbidity and mortality worldwide, with about 14 million new cases in 2012, and about 8.8 million deaths in 2015, according to the World Health Organization," said Arterys CEO Fabien Beckers. "A core Arterys mission is to help the medical community identify cancer earlier, so that patients can receive optimal treatment and improved prognosis. FDA clearance of our Oncology AI suite will help clinicians to quickly measure and track tumors over time. Additionally, our software enables seamless collaboration for clinicians, so second opinions can be easily gathered from within the hospital, or from outside experts."