Nanox scores clearance for cloud-connected X-ray bed after years of FDA review

Nanox has secured a long-awaited clearance from the FDA for its multi-source X-ray bed, designed to operate as a smaller, lighter imaging system in clinics and hospitals.

The Nanox.ARC can employ up to five separate X-ray-emitting tubes at once—mounted together above the patient on a tiltable gantry—to take multiple pictures of the inner body and digitally reconstruct them into a three-dimensional image, similar to a CT scan.

The agency’s clearance covers the stationary system’s use in adults, as well as its cloud-based computing infrastructure. The FDA previously handed a green light to Nanox’s Star Trek-inspired, single-source X-ray bed in early 2021

In its announcement this week, Nanox said it plans to offer access to its multi-source imager through a pay-per-scan business model—with scan readings and analyses being performed remotely through its teleradiology network.

Part of the plan is for the Israel-based company to place more systems in more rural areas, or regions that lack access to digital imaging and healthcare, after scaling up production and acquiring more regulatory approvals.

Nanox and its artificial intelligence-focused subsidiary—formerly known as Zebra Medical Vision—have also recently garnered FDA green lights for AI programs to help spot signs of osteoporosis, including areas of low bone density and compression fractures in the spine.

“Our vision is that Nanox's innovative technology and approach not only have the potential to increase access to medical imaging but also to shift healthcare from reactive to proactive—enabling early detection and prevention of diseases,” CEO Erez Meltzer said in a statement. 

Nanox’s most-recent journey through the FDA took longer than it originally anticipated. After first submitting its multi-source bed in 2021, the agency paused its review later that year and asked the company to provide more information. 

Nanox’s single-source bed had previously seen similar delays. Both it and its multi-source version are based on the company’s “cold cathode” emitter tube technology, pitched as a cost-effective alternative to the energy-intensive, superheated filaments used within traditional X-ray machines. Nanox has said that once cleared, its multi-source Nanox.ARC would take its place as the company’s flagship product.