News | Artificial Intelligence | February 29, 2024

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.

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.

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


Related Content

News | Magnetic Resonance Imaging (MRI)

July 2, 2025 — Philips has received FDA 510(k) clearance for SmartSpeed Precise[1] MR’s latest deep learning ...

Time July 03, 2025
arrow
News | Ultrasound Imaging

July 1, 2025 — UPDATE: The final paper is now available at: JMIR AI - ChatGPT-4–Driven Liver Ultrasound Radiomics ...

Time July 01, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

June 26, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for the Magnetom Flow.Ace, its ...

Time June 26, 2025
arrow
News | Prostate Cancer

June 26, 2025 – Quibim, a global provider of quantitative medical imaging solutions, has launched AI-QUAL, a new feature ...

Time June 26, 2025
arrow
News | PET-CT

June 19, 2025 — Building on a collaboration that spans more than three decades, GE HealthCare has renewed its research ...

Time June 19, 2025
arrow
News | Bone Densitometry Systems

June 19, 2025 — Naitive Technologies has published results demonstrating the diagnostic performance of its AI-powered ...

Time June 18, 2025
arrow
News | Lung Imaging

June 18, 2025 — Exo recently announced that now included on its Exo Iris is the first ever FDA 510(k) cleared AI for ...

Time June 18, 2025
arrow
News | Digital Pathology

June 11, 2025 — Diagnostic laboratory leaders view digital pathology and artificial intelligence (AI) as pivotal to ...

Time June 12, 2025
arrow
News | Lung Imaging

June 11, 2025 — To prepare healthcare workforces and providers for an AI-driven future, Qure.ai has expanded its Global ...

Time June 11, 2025
arrow
News | Radiology Imaging

June 10, 2025 — CIVIE has announced the official launch of RadPod, an AI-driven, on-demand radiology platform designed ...

Time June 10, 2025
arrow
Subscribe Now