The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.

The U.S. FDA gave the green light to Nanosonics Ltd.’s Coris system via de novo clearance for reducing infection risk by delivering improved cleaning outcomes for flexible endoscopes, especially the complex channels of endoscopes that are prone to biofilm build up.

In the first patenting from Lent Innovations LLC, the company’s founder, Anne Lent – an allergist and immunologist – describes their invention of an epinephrine auto-injector tailored to the specific needs of children to reduce the risk of use errors and incorrect injection technique.