Column | Patent and Regulatory Challenges in AI’s Use in Life Sciences | MedTech Intelligence

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The use of artificial intelligence (AI) in life sciences, or “Life Tech”, has increased at a rapid pace. According to World Intellectual Property Organization (WIPO), there has been “a shift from theoretical research to the use of AI technologies in commercial products and services,” as reflected in the change in ratio of scientific papers to patent applications over the past decade.1 Indeed, while research into AI began in earnest in the 1950s, more than 1.6 million scientific papers have been published on AI, with more than half of identified AI inventions in the last six years alone.2,3 A review article in Nature Medicine reported last year that despite few peer-reviewed publications on use of machine learning technologies in medical devices, FDA approvals of AI as medical devices have been accelerating.4 Many of these FDA approvals relate to image analysis for diagnostic purposes, such as QuantX, the first AI platform to evaluate breast abnormalities; Aidoc, which detects acute intracranial hemorrhages in head CT scans, assisting radiologists to prioritize patient injuries; and IDx-DR, which analyzes retinal images to detect diabetic retinopathy. Meanwhile, the use of AI in other, non-imaging-related medical fields is also actively being developed, including applications for diagnosing autism, selecting embryos …

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