RegulatorySpine

Zebra Medical Vision Secures its 5th FDA Clearance, Making Its Vertebral Compression Fractures AI Solution Available in the U.S.

May 18, 2020

KIBBUTZ SHEFAYIM, Israel–(BUSINESS WIRE)–Zebra Medical Vision, the 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. Nearly half of all women and a quarter of men over the age of 50 will suffer an osteoporotic fracture in their lifetime. 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.

Zebra-Med 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. 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.

“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”.

“Zebra-Med’s latest AI solution will be advantageous to value-based healthcare systems. With appropriate intervention, it has potential to reduce secondary fractures in high risk patients and reduce additional related costs, while enabling providers to benefit from higher Medicare star ratings and increased revenue from RAF score adjustments, ” says Dr. Keith White, Medical Director of Imaging Services, Intermountain Health.

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.

Read more on Zebra-Med’s blog: https://zebramedblog.wordpress.com/healing-our-fractured-world

About Zebra Medical Vision

Zebra Medical Vision’s imaging analytics platform allows healthcare institutions to identify patients at risk of disease and offer improved, preventative treatment pathways, to improve patient care. The company is funded by Khosla Ventures, Marc Benioff, Intermountain Investment Fund, OurCrowd Qure, Aurum, aMoon, Nvidia and Johnson & Johnson. Zebra Medical Vision has raised $52 million in funding to date, and was named a Fast Company Top-5 AI and Machine Learning company. Zebra-Med leads the way in AI FDA cleared products, and is installed in hospitals globally, from Australia to India, Europe to the U.S, and the LATAM region.

Contacts

Media:
Alona Stein
ReBlonde for Zebra Medical Vision
alona@reblonde.com

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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