Abbott receives FDA clearance for AI-powered heart imaging software

Abbott has received clearance from the Food and Drug Administration for its imaging software that uses artificial intelligence to provide doctors a better view of blood flow and blockages in heart vessels.
By Emily Olsen
11:41 am
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Photo: Andriy Onufriyenko/Getty Images

Abbott landed FDA clearance for its imaging software, which employs artificial intelligence to give doctors a clearer look at blood flow and blockages in heart vessels.

The Ultreon 1.0 Software pairs optical coherence tomography with AI to help physicians make decisions about next steps for treatment.

"As cardiologists continue to adopt OCT and move away from traditional imaging methods such as angiography, emerging technologies are pivotal to determine the best course of patient care," Dr. Nick West, chief medical officer and divisional vice president of global medical affairs at Abbott's vascular business, said in a statement.

"AI enables Ultreon Software to automatically detect calcium and vessel diameters, allowing doctors to put stents exactly where they are needed."

This is Abbott’s second FDA clearance this week. The company’s FreeStyle Libre 2 got the greenlight to allow users with diabetes to access their glucose levels on their iPhones without a reader.

WHY IT MATTERS

The Ultreon software has already received CE Mark clearance in Europe, and the technology was introduced to the Royal Free Hospital in London in May.

The OCT imaging helps physicians better view blockages, and assists with stent selection and placement, while AI can guide doctors during the procedure and improve accuracy.

"Abbott's new Ultreon Software for OCT provides an automated, comprehensive view of the artery that facilitates physician decision-making," Ziad Ali, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in New York, said in a statement.

"Ultreon Software guides stents to be placed with precision. These types of innovative technologies are instrumental in providing the best care for our patients."

THE LARGER TREND

AI has emerged in many aspects of health care, from AI-powered COVID-19 tests and chatbots that help patients in rural India to a pharmacy platform that touts safer medication dispensing.

According to a 2020 survey by Optum, 83% of health care organizations have an AI strategy, while another 15% were planning to create one. Last year, 59% of executives surveyed expected a return on their investment in AI in three years, compared with only 31% in 2018. The pandemic pushed more than half of executives in the survey to expand or accelerate their AI programs.

But AI does face barriers to widespread adoption. According to a 2020 white paper by IDC regarding hospitals in the U.S., U.K. and Germany, 32% of organizations questioned said there weren’t enough data scientists, data engineers and data modelers available for more extensive use of AI. In the U.S, 33% of hospitals said the top barrier was trustworthiness and bias in their data.

“As a nation, we really need to strengthen our health care data infrastructure and put a focus on improving digital health data,” said Christina Silcox, a policy fellow of digital health at the Duke-Margolis Center for Health Policy, at a CES 2021 virtual panel in January.

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