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The International Medical Device Regulators Forum has released two final guidance documents aimed at easing the filing process for marketing authorizations of medical devices and in vitro diagnostic devices in multiple countries. Read More
Swedish devicemaker XVIVO Perfusion has garnered an FDA’s humanitarian device exemption to market its donor lung preservation technology in the U.S. Read More
Manufacturers may soon be able to check how their devices are progressing through the 510(k) review process, under an experimental program being developed by the FDA. Read More
The FDA and Centers for Medicare & Medicaid Services have approved the first product ever under the two agencies’ joint pilot program for parallel review – Exact Sciences’ Cologuard, a noninvasive screening test for colorectal cancer. Read More
The FDA roundly rejected a citizen’s petition from the Minnesota Medical Device Alliance that had sought multiple changes to the 510(k) notification process. Read More