Nanox Imaging Ltd. (Nasdaq: NNOX) has announced that its Nanox.ARC imaging system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for general use, encompassing pulmonary, intra-abdominal, and paranasal sinus indications. This expands the system's utility beyond its initial clearance for musculoskeletal applications.
The Nanox.ARC system employs a proprietary digital X-ray source, leveraging advanced tomosynthesis technology with a cold cathode. This approach facilitates the creation of detailed, three-dimensional images, offering improved visualization compared to conventional 2D X-rays. The technology aims to reduce the superimposition of structures, enhancing diagnostic accuracy.
Broadening Clinical Applications
Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman, stated, "With this FDA clearance, we can now offer U.S. healthcare providers significantly broader imaging capabilities that are akin to commonly used traditional X-ray devices." The company's mission is to provide accessible, cost-effective solutions that enhance diagnostic imaging and patient care.
The newly cleared indications are expected to broaden the Nanox.ARC's commercial expansion within the U.S., where it is currently installed in multiple healthcare facilities across seven states. Globally, there are a few dozen units in various stages of shipment and deployment for commercial and clinical use.
Integration and Workflow Efficiency
The Nanox.ARC is designed for seamless integration into existing clinical workflows within hospitals, clinics, and imaging centers. Operated by trained radiographers, radiologists, and physicians, the system aims to reduce patient wait times, enable faster care, and improve diagnostic efficiency, potentially reducing the need for separate imaging facility visits.
Sherri Donaldson, COO at Diagnostic Radiology Institute of Kansas City, noted, "This technology allows us to provide our patients with advanced imaging services, potentially reducing wait times and improving the overall patient experience."
Technical Advantages
Greg Kicska M.D., Ph.D, Assistant Professor at Harborview Medical Center and Nanox Advisory Board Member, highlighted the system's unique features: "The Nanox system is also unique in that it doesn’t have as large a footprint as traditional X-ray machines, doesn’t require as much power and utilizes a matrix pattern that blurs out structural noise, making images more clean."
Market Impact
Cantor Fitzgerald upgraded its price target on Nano-X Imaging to $12 from $11, anticipating faster deployment of the systems due to the expanded indication for chest scans. Analyst Ross Osborn noted that approximately half of potential customers, accounting for around 200 systems, were awaiting the expanded indication. Existing units are equipped with the necessary hardware and can perform full-body scans with a simple software update.
