Arterys Receives FDA Clearance for Lesion and Tumor Detection Program

Arterys, the San Francisco-based medical imaging company, has just been granted Food and Drug Administration 510(k) clearance for their new Oncology AI suite that detects and tracks lesions and tumors in the liver and lungs using artificial intelligence (AI).

The clearance marks the latest accomplishment for Arterys. At this year’s annual Radiological Society of North America conference, they introduced MICA, a system that uses scalable GPU architecture to improve workloads.

The AI Suite analyzes specific nodules and lesions as a radiologist would by automating segmentation with impeccable accuracy. Clinicians are able to access these segmentations and edit them according to their clinical needs. The platform is available through an internet browser, allowing radiologists to easily confirm, assess, and report the existence of lung nodules and liver lesions while identifying their “key characteristics.” Arterys eventually plans on introducing quantifying systems for other organs.

“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,” said Arterys co-founder Albert Hsia, MD, PhD. “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.”