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Premarket submissions for flow cytometry devices should include a description of quality controls to ensure the device performs accurately throughout its lifecycle, the FDA says. This should include each analytical parameter reported by the device, including fluorescence intensity measures, when relevant. Read More
Bard’s Lutonix cleared the FDA hurdle, making it the first drug-coated angioplasty balloon catheter to treat peripheral artery disease in the leg approved for use in the U.S. But it could be another year or more before the technology wins over payers. Read More
Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
The FDA’s Circulatory Systems Devices Panel Wednesday recommended approval of Boston Scientific’s Watchman device, giving a nod to the left atrial appendage closure technology for an unprecedented third time. Read More
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