We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Devicemakers will be able to submit traditional 510(k)s electronically to two CDRH device branches, under an experimental program announced Thursday. Read More
The FDA may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by other factors such as postmarket controls, the agency says in draft guidance published Wednesday. Read More
Women now have an additional option for cervical cancer screening with the FDA’s Thursday approval of an expanded indication for a human papillomavirus diagnostic. Read More
The FDA Tuesday proposed a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Florida’s RTI Surgical is launching its Streamline OCT spinal fusion system in the U.S. after receiving 510(k) clearance last month, the company said Monday. Read More