Nanox AI's HealthOST Software Receives EU MDR CE Mark Certification, Enabling Commercialization Across Europe

Author: Benzinga Newsdesk | June 05, 2025 07:10am

• HealthOST identifies vertebral height loss and bone mineral density, which are key indicators of musculoskeletal disease
• Osteoporosis is a common progressive bone disease among adults over 50 years of age that causes bones to weaken, leading to fractures
• The software provides automated quantification of vertebral parameters from routine CT scans, delivering consistent and objective data to support physician evaluation, before life-altering fractures occur
  
   

PETACH TIKVA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ((", Nanox", or the ", Company", , NASDAQ:NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd, has received EU MDR CE (Conformité Européenne) mark certification for HealthOST, an SaMD (Software as a medical device) for bone health analysis, enabling its commercialization across Europe and ensuring compliance with the highest regulatory standards for medical software.

HealthOST is Nanox.AI's advanced Bone Solution, which analyzes routine CT scans to assess vertebral height loss and bone mineral density. Building on its FDA 510(k) clearance received in April 2022, HealthOST leverages AI to provide qualitative and quantitative analysis of the spine from CT scans to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine, such as osteoporosis, which can remain undiagnosed until life-altering fractures occur.

Posted In: NNOX