Articles of Interest

Mikie Sherrill’s new bill would tie federal reimbursement to testing result times—and reward labs for extra quick turnarounds.

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

Information about CDRH's Digital Health Program

Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care.

Is the agency providing enough guidance and direction to industry?

Film production in the U.S. may have been halted by the coronavirus, but it's the lack of widely available testing that will keep it from resuming fully this fall.

Mobile App concept to facilitate reporting Coivd-19 cases, looking for near by testing labs, hospitals, self-help, talking to experts online, buying essentials and much more.

EUA Authorized Serology Test Performance

A software update allows Ford police SUVs to sterilize themselves.