Zebra Medical Vision Gains FDA Clearance for Spine Fracture AI Solution

By Julie A. Vetalice

Zebra Medical Vision Gains FDA Clearance for Spine Fracture AI Solution

Zebra Medical Vision gained a fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The company’s artificial intelligence (AI) solution automatically identifies findings that suggest compression fractures, allowing clinicians to place patients at risk of osteoporosis into treatment pathways to prevent fractures.

The VCF product expands the company’s AI1™ (all-in-one) bundle of AI solutions. The company is the first AI start-up 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.

The software substantially increases detection rates, raising the number of patients eligible for treatment without the need for additional staff, imaging or radiation.

Zebra-Med’s AI technology uses algorithms to create three-dimensional models from x-ray images as an affordable alternative to CT scans and MRI imaging for pre-operative surgical planning. It may enable more frequent use of other tools, like patient-specific instruments or robotic assistance, without using traditional MRI or CT-based imaging.

This technology will be introduced as part of DePuy Synthes’ VELYS Digital Surgery solutions for pre-operative, operative and post-operative patient care.

"Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70% 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."

Tags: 510(k) Clearance, Regulatory