Lexology January 26, 2023
The development and adoption of artificial intelligence (AI) in the medical space, and in particular the imaging-intensive specialties, continues to grow rapidly. At the time of publication, the FDA’s website reflected approximately 91 clearances of AI-enabled medical devices in 2022, with around 79 of those being reviewed by radiology panels at the FDA.
This trend is not unexpected, as the FDA has approved or cleared roughly 392 such devices since 1995. Among this group are three clearances of 510(k) submissions made by iCAD, Inc. These “devices” are all software programs targeted at assisting healthcare professionals in assessing mammography results and, in particular, detecting cancerous lesions via tissue density analysis.
iCAD is far from the only developer working in this corner...
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