The Trump's legacy
😰 The last days of Trump administration will have a lasting (and potentially very dangerous) implication in the use of AI in medical imaging equipment. Why ?
🗞️ The Trump Administration is reportedly “forcing through a steady stream of changes in its final days”, and one of the decisions was about eliminating FDA 510(k) / PMA review requirements for 84 Class II medical device types, including a list of imaging equipment and imaging AI. A process that was already defined as “quickie, down and dirty, which doesn’t require any clinical testing.” by an investigative journalist : Jeanne Lenzer
🚨 These changes have alarmed many in the FDA and healthcare community, including former FDA commissioner Scott Gottlieb, while the imaging community is trying to wrap their heads around what happens if premarket reviews are eliminated. The Class II devices that would be exempt from premarket reviews includes a relatively wide range of imaging AI categories and imaging systems
🐦 In Tweeter this decision has been thoroughly commented by a fellow doctor : “They justify this on a lack of reported adverse events in the MAUDE database. […] AI has barely hit the market, so of course there aren’t many safety reports yet!”