May 14, 2015 by Brad Perriello
The FDA yesterday warned hospitals about a security risk with 2 models of Hospira drug infusion pumps, citing an independent researcher’s discovery of a flaw that could allow hackers to manipulate the devices.
Security researcher Billy Rios found that hackers could upload a new drug library into Hospira’s remotely-programmed LifeCare PCA3 and PCA5 devices, thereby altering their dosage limits, according to Wired magazine. That creates a risk for potentially deadly doses of anesthetic or pain drugs. Read more
May 12, 2015 by MassDevice
Health Canada has released new information regarding common issues its reviewers found over the course of 2014 and early 2015 with higher-risk Medical Device License (MDL) applications that result in additional information requests to applicants.
In a Health Canada performance report provided by Canadian trade association MEDEC, the most common requests for additional information for Class III and IV new and amended MDL applications include: Information on safety and effectiveness studies; Documentation on device and package labeling; Background information; Marketing history and regulatory status. Read more
May 18, 2015 by Fink Densford
Arterial Remodeling Technologies said it won CE Mark approval in the European Union for its bioreabsorbable stent for treating coronary artery disease.
ART’s Pure Bioreabsorbable Scaffold is designed to relinquish its primary function within 3 months and be completely reabsorbed into implanted body after 24 months, the company said. Read more
May 18, 2015 by MassDevice
New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity.
Known as adaptive design, the method can minimize clinical trial sponsors’ resource requirements and increase chances of study success. By spelling out when adaptive designs are acceptable in clinical trials for devices requiring Premarket Approval (PMA) or 510(k) premarket notification, the FDA seeks to better inform both device manufacturers and its own review staff on the benefits and proper implementation of adaptive designs. Read more