An inside look at the changing culture of the FDA

The FDA has reduced its direct communication and engagement with the healthcare technology industry amid uncertain regulatory direction under the current administration, creating challenges for innovators, especially in digital health. Staffing changes and workplace policy shifts have also impacted the agency's ability to share expertise, though there is hope for a return to greater transparency and guidance publication to support AI-enabled medical technology development.

This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure.