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The FDA and Centers for Medicare & Medicaid Services’ parallel review pilot program continues to face hurdles, even while products released through the program have reached the U.S. market, officials of both agencies say. Read More
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