The VCF solution can be used to perform abdominal or chest CT scan for any clinical indication
Israeli medical devices firm Zebra Medical Vision (Zebra-Med) has secured the US Food and Drug Administration FDA 510(k) approval for its Vertebral Compression Fractures (VCF) solution.
The company said that its new AI solution is designed to automatically identify the findings suggestive of compression fractures to help clinicians in placing patients who are at risk of osteoporosis into treatment pathways to avert potential fractures.
The VCF product expands the company’s growing portfolio of FDA approved AI solutions, which has secured the fourth US patent in its bone health series.
Zebra Medical Vision CEO Ohad Arazi said: “Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 percent of vertebral compression fractures are underdetected globally.
“These missed care opportunities are especially vital during this era of COVID-19, when many patient procedures have been postponed, and providers are dealing with substantial backlogs.
“The VCF product, our fifth FDA-cleared solution on the market—will allow us to expand our reach in the U.S. and help more clinicians and caregivers identify a large number of these fractures.”
The new VCF solution can be used to perform abdominal or chest CT scan
Zebra-Med is said to be the first medical imaging start-up to receive FDA approval for a population health solution, which leverages AI to stratify risk, improve quality of life, and reduce cost of care for patients.
The company said that its software is developed to improve detection rates, increase the number of patients eligible for treatment, and prevent the need for additional staff, imaging or radiation.
Zebra Medical Vision will help centres offering fracture-prevention programmes or population-management programmes, to systematically onboard people, initiate further examinations and treatment.
The new vertebral compression fractures solution has been deployed in luminary sites including Oxford University Hospital (UK) and St. Vincent’s hospital in Australia.
The VCF solution can be used to perform abdominal or chest CT scan for any clinical indication.
Intermountain Health imaging services medical director Keith White said: “Zebra-Med’s latest AI solution will be advantageous to value-based healthcare systems.
“With appropriate intervention, it has potential to reduce secondary fractures in high risk patients and reduce additional related costs, while enabling providers to benefit from higher Medicare star ratings and increased revenue from RAF score adjustments.”