The U.S. FDA announces that it has been “closely monitoring” how the closures of certain large-scale sterilization facilities that use ethylene oxide gas to sterilize medical devices prior to their use will impact the healthcare sector.
Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.
The U.S. FDA has granted 510(k) clearance to Carlsbad, Calif.-based Alphatec for its SafeOp neuromonitoring system for use in spine surgery procedures. Based on the Alpha Informatix platform, the automated system is designed for intraoperative nerve location and health assessment in real time.
Medtronic is notifying customers worldwide of a voluntary field corrective action—a software update—for its Puritan Bennett 980 (PB980) ventilator series. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality and the labeling displayed on the GUI during ventilator use, Medtronic said in a statement.
Ann Arbor, Mich.-based NSF International has launched a comprehensive set of online training modules covering global medical device regulatory requirements for all five countries participating in the Medical Device Single Audit Program (MDSAP). The company’s new online program includes interactive training, tools, and video-based courses, NSF International officials say.
The U.S. FDA has issued final guidance that details its Q-submission program, a voluntary avenue for developers of medical devices to collaborate with and get feedback from the agency before committing to a premarket submission.