Nanox, U.S. FDA Single Source NanoxArc U.S. FDA 510(k) Clearance

[Asia Economy Reporter Hyungsoo Park] Nanox, an innovative medical imaging diagnostic technology company listed on the US Nasdaq, announced on the night of the 2nd (local US time) that its single-source Nanox.ARC digital X-ray technology received 510(k) clearance from the US Food and Drug Administration (FDA).

Nanox, an innovative technology company invested in by SK Telecom, Yozma Group Korea, Fujifilm, and Foxconn, plans to apply for FDA 510(k) clearance for its multi-source Nanox.ARC and Nanox Cloud this year, following the FDA approval of the single-source system. Once approved, the multi-source Nanox.ARC is expected to be widely deployed worldwide as a commercial imaging diagnostic system.

Through its third-largest shareholder Yozma Group Korea, Nanox was introduced to Korean manufacturing companies and is establishing a core component manufacturing plant in Korea. Earlier this year, Nanox purchased a 3,600-pyeong site in Yongin and is currently building the factory. Approximately $40 million will be invested within this year for the Korean production base.

Nanox is matching software companies that can be integrated into the Nanox system together with Yozma. Currently, it is discussing technical cooperation with multiple Korean startups.

Ran Poliakine, Chairman and CEO of Nanox, stated, “Nanox has made significant progress in its regulatory approval plans in the US by obtaining FDA 510(k) clearance.” He added, “We are on track to begin the initial deployment of 15,000 Nanox.ARC systems in the fourth quarter of this year and the first quarter of next year, completing it by 2024 as planned.”

He also said, “Nanox believes it is well positioned to achieve its goal of popularizing imaging diagnostics and expanding the market to two-thirds of the global population who have limited access to imaging diagnostics and preventive medicine.”

This content was produced with the assistance of AI translation services.