The FDA Just Qualified Its First AI Drug-Development Tool And It Could Reshape How We Run Trials
For years, the industry has talked about AI transforming clinical research. Now, the FDA has taken the conversation out of the hypothetical. The Agency has officially qualified the first artificial-intelligence tool for use in liver-disease drug development: a cloud-based system called AIM-NASH that reads and scores liver-biopsy images. This isn’t an approval for clinical care. […]