Category: FDA Updates

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SafeOp Neuromonitoring System Nabs FDA Clearance

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.

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Medtronic Announces Voluntary Field Corrective Action for Ventilator Series

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.

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NSF International Launches Online Training on Medical Device Regulations for MDSAP Countries

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.