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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
Cardiologists will be looking to Europe for pipeline updates this year, particularly on Thoratec’s HeartMate III and HeartWare’s MVAD pump, analysts say. Read More