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Nano-X Imaging Ltd. Reports CE Certification for Nanox.ARC in Form 6-K

$NNOX
Form 6-K
Filed on: 2025-02-25
Source
Nano-X Imaging Ltd. Reports CE Certification for Nanox.ARC in Form 6-K

Based on the provided section of the financial report for Nano-X Imaging Ltd., here are the key insights and information extracted:

  1. Type of Filing: This is a Form 6-K, which is typically used by foreign private issuers to report information that is of importance to shareholders or investors.
  2. Commission File Number: 001-39461, which is used to identify the registrant in SEC filings.
  3. Company Information:
  • Name: Nano-X Imaging Ltd.
  • Address: Ofer Tech Park, 94 Shlomo Shmeltzer Road, Petach Tikva, Israel, 4970602.
  1. Report Date: The report pertains to the month of February 2025, with significant news dated February 25, 2025.
  2. Key Announcement: The company announced that it has received CE (Conformité Européenne) mark certification for its multi-source Nanox.ARC system. This certification allows them to market the device in Europe.
  • Product Description: The Nanox.ARC is a stationary X-ray system designed to generate tomographic images of human anatomy from a single tomographic sweep, specifically for adult patients in recumbent positions.
  1. Incorporation by Reference: The contents of Exhibit 99.1, which includes a press release from February 25, 2025, are incorporated by reference into the registration statements on Form F-3 and Form S-8 filed with the SEC.
  2. Signatory Information: The report is signed by Ran Daniel, who is the Chief Financial Officer of the company.
  3. Filing Requirements: The report indicates that the registrant intends to file annual reports under Form 20-F, which is typical for foreign companies that trade on U.S. exchanges.

This report is significant as it highlights a regulatory milestone for Nano-X Imaging, which could have implications for its market presence in Europe and potentially influence investor sentiment. The CE mark certification is a critical step for medical devices entering the European market, indicating compliance with safety and efficacy requirements.