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The UK’s health cost-benefit watchdog said Wednesday that there is insufficient evidence on two promising new skin care technologies to justify their routine use. Read More
The FDA plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More
The Center for Devices and Radiological Health is steadily chipping away at premarket approval and 510(k) review times, but not fast enough to compete with EU approval times, according to a new report. Read More
The U.S. Food and Drug Administration last month issued final guidance outlining the steps manufacturers of medical device software must take spurn cybersecurity threats. Read More
Devicemakers seeking authorization to market Class II products in Canada will have to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More