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More devicemakers are choosing the de novo approval pathway to get novel low-risk technologies to market quickly, thanks to changes in the way the FDA reviews these products that took effect two years ago. But knowing how to pitch a petition is key to success, an expert says. Read More
Cataract patients who also have astigmatism may soon have a new option for restoring vision, if the FDA heeds a recent advisory panel recommendation. Read More
The FDA wants additional data and a revised indication for use before it will approve an ultrasound treatment for prostate cancer, according to an unapprovable letter sent to French devicemaker EDAP. Read More
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