Therapy Areas: Cardiovascular
Nanox Receives FDA Clearance for HealthOST Device, an AI Software Measuring Vertebral
28 April 2022 - - Israel-based medical imaging technology company Nano-X Imaging Ltd's (NASDAQ: NNOX) Nanox.AI subsidiary has received FDA 510(k) clearance for HealthOST device, an AI software that provides qualitative and quantitative analysis of the spine from CT to support clinicians in the evaluation and assessment of musculoskeletal disease, the company said.

Measurements of vertebral fractures and low bone density have been shown to increase the identification of patients with musculoskeletal disease of the spine, such as osteoporosis, a disease that affects more than 10m people in the US.

This is Nanox.AI's tenth FDA clearance across its innovative portfolio of AI clinical decision assist tools and second FDA clearance for its vertebral compression fracture device.

HealthOST offers a more detailed evaluation, including the ability to measure fractures more precisely, potentially aiding clinicians in evaluating risk factors for osteoporosis.

The company's latest AI solution automatically identifies findings suggestive of compression fractures and low bone density, enabling further work up and treatment of patients diagnosed with osteoporosis to prevent potentially life-changing major osteoporotic fractures, such as a hip fracture.

Nanox.AI previously received FDA clearance in May 2020 for the AI software that identifies vertebral compression fractures.

HealthOST provides qualitative and quantitative analysis of the spine, including labelling of T1-L4 vertebrae, measurement of height loss in each vertebra (T1-L4) and measurement of the mean Hounsfield Units in volume of interest within vertebra (T11-L4).

HealthOST is indicated for use in patients aged 50 and over undergoing CT scan for any clinical indication that includes at least four vertebrae in the T1-L4 portion of the spine (for vertebral height loss) and T11-L4 (for bone attenuation) portions of the spine.

Nanox.AI's portfolio also includes HealthCCSng, an FDA-cleared AI cardiac imaging solution that quantifies coronary artery calcium, to identify patients potentially at risk for a cardiovascular event, to promote further work up and possible treatment for cardiac disease.

Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe.

Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world.


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