Zebra Medical Vision announced today that it received its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product.
The Kibbutz Shefayim, Israel-based company’s latest artificial intelligence-based product automatically identifies findings suggestive of compression fractures, which enables clinicians to place patients that are at risk of osteoporosis in treatment pathways that can prevent potentially life-changing fractures.
VCF expands Zebra’s AI1 bundle of FDA-cleared AI products, which now has a fourth U.S. patent in its bone health series, according to a news release. Zebra touts itself as the first AI startup in medical imaging to receive FDA clearance for a population health solution.
“Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 percent of vertebral compression fractures are under detected globally,” Zebra CEO Ohad Arazi said in the news release. “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”.