Abbott receives FDA clearance for AI-powered coronary heart imaging software program

Abbott landed FDA clearance for its imaging software program, which employs synthetic intelligence to provide docs a clearer take a look at blood movement and blockages in coronary heart vessels.

The Ultreon 1.0 Software program pairs optical coherence tomography with AI to assist physicians make selections about subsequent steps for remedy.

“As cardiologists proceed to undertake OCT and transfer away from conventional imaging strategies equivalent to angiography, rising applied sciences are pivotal to find out the perfect course of affected person care,” Dr. Nick West, chief medical officer and divisional vp of worldwide medical affairs at Abbott’s vascular enterprise, mentioned in a press release.

“AI permits Ultreon Software program to robotically detect calcium and vessel diameters, permitting docs to place stents precisely the place they’re wanted.”

That is Abbott’s second FDA clearance this week. The corporate’s FreeStyle Libre 2 obtained the greenlight to permit customers with diabetes to entry their glucose ranges on their iPhones with out a reader.


The Ultreon software program has already obtained CE Mark clearance in Europe, and the expertise was launched to the Royal Free Hospital in London in Might.

The OCT imaging helps physicians higher view blockages, and assists with stent choice and placement, whereas AI can information docs in the course of the process and enhance accuracy.

“Abbott’s new Ultreon Software program for OCT supplies an automatic, complete view of the artery that facilitates doctor decision-making,” Ziad Ali, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Coronary heart Heart in New York, mentioned in a press release.

“Ultreon Software program guides stents to be positioned with precision. These kinds of progressive applied sciences are instrumental in offering the perfect take care of our sufferers.”


AI has emerged in lots of facets of well being care, from AI-powered COVID-19 checks and chatbots that assist sufferers in rural India to a pharmacy platform that touts safer medicine allotting.

In line with a 2020 survey by Optum, 83% of well being care organizations have an AI technique, whereas one other 15% have been planning to create one. Final yr, 59% of executives surveyed anticipated a return on their funding in AI in three years, in contrast with solely 31% in 2018. The pandemic pushed greater than half of executives within the survey to broaden or speed up their AI applications.

However AI does face boundaries to widespread adoption. In line with a 2020 white paper by IDC concerning hospitals within the U.S., U.Okay. and Germany, 32% of organizations questioned mentioned there weren’t sufficient information scientists, information engineers and information modelers out there for extra intensive use of AI. Within the U.S, 33% of hospitals mentioned the highest barrier was trustworthiness and bias of their information.

“As a nation, we actually have to strengthen our well being care information infrastructure and put a give attention to bettering digital well being information,” mentioned Christina Silcox, a coverage fellow of digital well being on the Duke-Margolis Heart for Well being Coverage, at a CES 2021 digital panel in January.

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