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The FDA has posted the second warning letter in two weeks for Baxter Healthcare, this one citing supplier control slips and other issues at its Irvine, Calif., manufacturing plant. Read More
Neuropsychiatric interpretive EEG assessment aids should undergo clinical performance testing to demonstrate the accuracy, precision and reproducibility of results, including any specified cutoffs, the FDA says. Read More
FDA’s continued progress under MDUFA is allowing AdvaMed to shift some of its focus from the pace of premarket reviews and approvals to the Center for Medicare & Medicaid Services’ methods for making coverage decisions on new technologies, association officials said Tuesday. Read More
The 2.3 percent excise tax on medical devices that took effect in January 2013 has been less harmful than industry feared, producing lower-than-expected price increases for consumers, a new survey finds. Read More
Devicemakers planning a PMA or product development protocol should take advantage of presubmission determination meetings with the FDA to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More
Baxter Healthcare landed an FDA warning letter that includes multiple repeat observations and issues related to test methods, CAPAs and over-infusion with its elastomeric infusion systems. Read More
Royal Philips said Tuesday it had reached an enrollment goal of 2,500 patients in its Sleep Apnea cardioVascular Endpoints (SAVE) trial. Preliminary results are expected in 2016. Read More
Kennesaw, Ga.-based CryoLife is expanding its footprint in the Asia/Pacific market, establishing CryoLife Asia Pacific as a wholly owned subsidiary of the parent corporation. Read More