Nano-X Imaging Ltd. ( NNOX ) shares are trading higher Thursday after the company announced FDA clearance for its Nano.ARC stationary x-ray system.

What To Know: Nano-X said it received 510(k) clearance from the FDA for its Nanox.ARC system, expanding the device’s use to include pulmonary, intra-abdominal and paranasal imaging in addition to its previously cleared musculoskeletal indications.

The Nanox.ARC system uses advanced tomosynthesis technology and a cold cathode digital X-ray source to produce three-dimensional tomographic images. The technology reduces the overlap of anatomical structures common in traditional 2D X-rays, and is intended for professional use in hospitals, imaging centers and clinics.

According to the company, the device has a smaller footprint and lower power requirements than conventional X-ray machines. It integrates with existing clinical workflows and aims to reduce patient wait times and streamline diagnostic processes.

Erez Meltzer, CEO and acting chairman of Nano-X, stated that the clearance allows the company to offer broader imaging capabilities comparable to traditional X-ray devices. Meltzer emphasized the technology's role in improving diagnostic access and efficiency.

“Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC – an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care,” Meltzer said.

The Nanox.ARC is deployed in healthcare facilities across seven U.S. states and is undergoing deployment internationally for both clinical and commercial applications. The company anticipates that the expanded FDA-cleared indications will support further U.S. market growth.

Greg Kicska, a member of the company's advisory board, noted that the system could add value in specific clinical settings, such as musculoskeletal, thoracic and abdominal imaging. He highlighted technical advantages, including reduced structural noise and a more compact design.

NNOX Price Action: Nano-X Imaging ( NNOX ) shares were up 3.66% at $6.48 at the time of writing, according to Benzinga Pro.

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