AIxSCAN, Inc. has issued an update on its plans to produce over 50 lung disease patients scans with its ARC60, an AI-based tomosynthesis X-ray imaging system ahead of requesting 510k U.S. Food and Drug Administration (FDA) approval in 2024.
February 29, 2024 — AIxSCAN, Inc., a Sunnyvale, CA-based developer of a next generation artificial intelligence (AI)-based tomosynthesis X-ray imaging system, has reported that its team, which began clinical trials in late 2023, is very pleased with the early ARC60 imaging results, both in terms of depiction of details and consistency of imaging quality.
A company statement noted that AIxSCAN, Inc. received additional seed funding in early Sept., 2023 to support clinical trials and engineering projects, and that University of California San Diego Health is the first site for the clinical trials to be conducted. In addition,
AIxSCAN, Inc. is in final discussions to partner with three more institutions as soon as additional ARC60 units come out of production.
Planning for Lung Disease Scanning
Between late 2023 and early 2024, AIxSCAN, Inc. plans to produce over 50 lung disease patients scans in the U.S. and up to 1,000 total lung disease patients scans within 2 years. AIxSCAN, Inc. will use some of the data to support its 510k submission to the FDA in 2024.
“This innovative technology has the potential to change the way we diagnose a range of medical conditions,” according to Norbert Pelc, Sc.D., Professor of Radiology, Emeritus at Stanford University and AIxSCAN, Inc. Advisory Board member, commenting on the ARC60 imaging platform capabilities. Pelc added, “The AIxSCAN tomosynthesis X-ray scanner does not completely avoid the superimposition limitations of radiography, but the early results from the prototype system are very encouraging and suggest the technology can play a significant role. I believe that AIxSCAN's tomosynthesis X-ray scanner has a very good chance of becoming a valuable tool for the medical community. This technology has the potential to improve patient care and save lives.”
Technological Development and Focus Areas
AIxScan leverages cutting-edge AI and hardware advancements to redefine X-ray imaging. By optimizing algorithms, our system achieves short screening times, large-angle imaging, and ultra-high resolution, ensuring swift and precise diagnostics. The company update specified that AIxSCAN, Inc. is introducing the next generation tomosynthesis X-ray imaging system, which combines the functionalities of digital radiography (DR), computerized tomography (CT), and an experienced radiologist into a single package. It reports that the patent-protected, direct AI-based medical X-ray imaging system is a paradigm-shift from conventional digital radiography (DR) and computed tomography (CT), aimed to enable accurate diagnoses and tracking of abnormalities over time. With this technology, the company aims to complete a scan, assist the physician in providing a diagnosis, and create a report efficiently and at a low radiation dose (from 1/20 to 1/40 that of typical CT).
More information: www.aixscan.com
May 15, 2025 
