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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
Heart patients in the U.S. would no longer have access to Medtronic’s CoreValve transcatheter valve if a preliminary injunction handed down in federal court takes effect. Read More
The U.S. Food and Drug Administration does not mandate the use of specific international standards, allowing manufacturers to explore science-based alternatives. Read More
The U.S. Food and Drug Administration may withdraw a humanitarian device exemption if it subsequently approves a premarket approval application or clears a 510(k) for a humanitarian-use device or a comparable device with the same indication, draft Q&A guidance explains. Read More
The China Food and Drug Administration last month unveiled long-awaited reforms to its medical device regulations, breathing longer life into product licenses, but imposing first-time fees for device registrations. Read More