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Home » Zebra Medical Vision wins FDA clearance for AI to predict osteoporosis

Zebra Medical Vision wins FDA clearance for AI to predict osteoporosis

May 18, 2020 By Sean Whooley

Zebra Medical VisionZebra 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”.

Filed Under: 510(k), Digital Health, Food & Drug Administration (FDA), Health Technology, Imaging, Orthopedics, Regulatory/Compliance, Software / IT Tagged With: artificial intelligence, FDA, Zebra Medical Vision

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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