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As more devicemakers branch into mobile medical apps, one common mistake they make is treating off-the-shelf hardware and software the same as hardware and software made in-house, an expert says. Read More
SonaCare Medical’s hopes of marketing a new treatment for prostate cancer were dealt a setback Wednesday when an FDA advisory group recommended against approving the company’s Sonablate 450. Read More
Makers of low and moderate risk devices can now use the U.S. Food and Drug Administration’s de novo pathway to gain approval without first filing for 510(k) clearance — a route the agency hopes devicemakers will take. Read More
Devicemakers could see their wait time to begin clinical trials cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current practice. Read More
The European Commission will soon launch an internal test of the International Medical Device Regulators Forum’s table of contents for medical devices and IVDs — documents designed to ease marketing authorizations process when companies file in multiple countries. Read More