Nanox obtains CE mark for AI bone health software

Nano-X Imaging's (Nanox) deep learning subsidiary Nanox AI has received CE marking for HealthOST, which analyzes routine CT scans to assess vertebral height loss and bone mineral density.

The company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the software in 2022. HealthOST aims to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine, such as osteoporosis.

Since the CT scans analyzed by HealthOST are performed for other clinical indications, no additional imaging, radiation, or patient time is required, the company highlighted. It can also be integrated into an existing PACS.

HealthOST is the upgraded version of HealthVCF. The latter was evaluated in the AI-enabled Detection of OsteoPorosis for Treatment (ADOPT) study at four U.K. National Health Service (NHS) trusts and coordinated by the longstanding clinical users at Oxford.

For the study, the software analyzed 37,220 routine medical CT scans and identified over 3,450 new asymptomatic patients with vertebral compression fractures.

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