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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