FDA clears new cold cathode tomosynthesis system
The U.S. Food and Drug Administration has just granted clearance for a new digital tomosynthesis system that makes use of cold cathode technology.
Nanox announced the clearance of Nanox.ARC X on Thursday, highlighting the system’s expedited path to approval, which was granted just 30 days from the digital imaging technology’s date of submitting their application. Nanox.ARC X is a digital tomosynthesis system that provides 3D CT-like images of the body.
Cold cathode tubes do not require additional structures and cooling components to reduce heat the same way traditional X-ray equipment does. This makes for a smaller system that is lighter in weight and requires less energy to operate, also resulting in decreased costs.
Nanox touts a “plug and play” installation for their new system that takes just one day. The cable-free system operates on standard power (110v/230v 16A) and does not require additional infrastructure or large spaces, as it can be used in any standard radiation-safe room. It has been approved for all general use.
“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” Chief Executive Officer and Acting Chairman of Nanox, Erez Meltzer, said in a release on the clearance. “By integrating our proprietary digital technology in this new imaging system, we’re making it easier for healthcare providers to adopt digital 3D imaging. This milestone advances our mission to expand access to essential medical imaging technology to more patients, regardless of their location. We look forward to introducing further capabilities to the Nanox.ARC X in the future and making them available through remote and immediate upgrades.”
Nanox has indicated that the new cold cathode system will be available for purchase later this year alongside the current Nanox.ARC system.
The clearance comes after Nanox found itself facing multiple legal woes in recent years. In August 2023, the company and its former CEO had to pay more than $1 million to settle charges stemming from a federal investigation into its business practices, according to the U.S. Securities and Exchange Commission.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.