DOTmed February 14, 2023
As of January 2023, over 520 AI algorithms have gotten the green light from FDA for distribution in the U.S., with the majority designed for use in medical imaging.
While the number of algorithms in other specialties are not even in the triple digits, the FDA recorded 396 in radiology, according to Health Exec. AI’s high accuracy in pattern recognition has boosted diagnostic capabilities, leading to a concentration of market approvals in medical imaging.
Most are approved for imaging across specific subspecialties, such as the brain, breast, cardiac, lung and stroke. The first was cleared by the FDA in 1995, with fewer than 50 more approved over the next 18 years. But in the last decade, approvals have skyrocketed, with...
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