Zebra Medical Vision has become the first company to receive US FDA approval for an AI-based imaging approach to identifying those at high risk of developing osteoporosis.
Nearly half of all women and a quarter of men over the age of 50 will reportedly suffer an osteoporotic fracture in their lifetime.
It is said to be the most common preventable cause of fractures, causing more than 2 million cases of broken bones and costing health services around $52 billion in the U.S. alone every year.
Zebra Medical Vision’s deep-learning, AI-based imaging technology Vertebral Compression Fractures (VCF) automatically identifies findings suggestive of compression fractures.
This allows clinicians to intervene before life-threatening incidents can occur.
The VCF has now received Zebra’s fifth FDA 510(k) clearance, meaning the product is now available for use in the US.
Ohad Arazi, CEO of Zebra Medical Vision, said: “Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 per cent of vertebral compression fractures are undetected 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 US and help more clinicians and caregivers identify a large number of these fractures.”