Zebra Medical Vision, the Israeli-based deep-learning medical imaging analytics company, announces today its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The company’s latest AI solution automatically identifies findings suggestive of compression fractures, enabling clinicians to place patients that are at risk of osteoporosis in treatment pathways to prevent potentially life-changing fractures. The VCF product expands the company’s growing AI1™ (all-in-one) bundle of FDA cleared AI solutions, which has now received a fourth US patent in its bone health series.
Osteoporosis: The Silent Killer
According to the National Osteoporosis Foundation (NOF), the cost of osteoporosis-related fragility fractures to the U.S. is estimated to be $52 billion annually. Osteoporosis, also referred to as “The Silent Killer,” is the most common preventable cause of fractures, causing more than 2 million cases of broken bones in the U.S. alone every year. Vertebral compression fractures (VCF) are a direct cause of morbidity, decreasing mobility and functional status particularly among the elderly. Detection of VCF’s is paramount in the effort to decrease secondary osteoporotic fractures – the most morbid of which are hip fractures. Diagnosing VCF’s is therefore of critical importance for the implementation of both primary therapeutic and secondary preventative interventions. Nearly half of all women and a quarter of men over the age of 50 will suffer an osteoporotic fracture in their lifetime.
Impact of FDA Clearance
Today’s announcement marks Zebra-Med as one of the first digital health startups in medical imaging to receive FDA clearance for a population health solution, which leverages AI to stratify risk, improve patient’s quality of life, and reduce cost of care. Zebra’s bone health algorithm detects vertebral compression fractures and can be applied to any CT of the chest or abdomen. The software substantially increases detection rates, raising the number of patients eligible for treatment, without the need for additional staff, imaging or radiation. Sites that run fracture-prevention programs or population-management programs use Zebra Medical Vision to systematically onboard people to these programs and initiate further examinations and treatment.
The company’s vertebral compression fractures solution has been deployed globally in luminary sites such as Oxford University Hospital (UK) and St. Vincent’s hospital (Australia). The solution can be applied to abdominal or chest CT scan performed for any clinical indication.
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“Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 percent of vertebral compression fractures are underdetected globally” says Ohad Arazi, CEO of Zebra Medical Vision. “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”.
Source: HIT Consultant