Nanox.AI, a deep-learning medical imaging analytics subsidiary of NANO-X, has received 510(k) clearance from the US Food and Drug Administration (FDA) for artificial intelligence (AI) software, HealthOST device.
The device is intended to provide qualitative and quantitative analysis of the spine from CT to aid doctors in the assessment of musculoskeletal diseases.
It can offer a more thorough examination, including the ability to accurately assess fractures, supporting physicians in determining osteoporosis risk factors.
Nanox.AI general manager Pini Ben Elazar said: “With the FDA clearance of HealthOST, we are thrilled to offer radiologists a new tool that provides deeper analysis of medical images to support identifying those patients who may be at risk of developing prevalent musculoskeletal conditions such as osteoporosis, to help promote further work up and treatment of those patients.
“Our new product reflects our vision to create solutions to improve population health, building upon our strong track record of developing AI applications to help identify risk factors for chronic health conditions.”
HealthOST is the tenth addition to the firm’s portfolio of AI clinical decision assist tools and the second FDA clearance for its vertebral compression fracture device.
The company’s latest AI solution detects data that are suggestive of compression fractures and poor bone density, allowing individuals diagnosed with osteoporosis to be further evaluated and treated to avoid potentially life-changing catastrophic osteoporotic fractures, such as a hip fracture.
Nanox CEO Erez Meltzer said: “This FDA clearance is yet another step in our commitment to delivering technologies that promote population health and value-based care.
“AI technologies like HealthOST are poised to support routine clinical decision making and potentially improve patients’ health outcomes.”
In May 2020, Nanox.AI secured FDA approval for AI software that detects spinal compression fractures.
