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Data from a post-approval study supported an updated indication for patients “without the presence of profound shock, end organ failure or acute neurologic injury,” the agency said. Read More
Results from a clinical trial showed a 62 percent reduction in physician misses of aortic calcification and a 33 percent reduction in misses of dilated aortas, the company said. Read More
Brisbane, Calif.-based Cutera, a manufacturer of medical aesthetic and dermatology devices, was hit with an FDA warning letter for a still-functioning website for a vaginal rejuvenation product the company removed from the market in 2019. Read More
The FDA has approved updated labeling of Abiomed’s Impella RP system to better characterize the type of patients who may benefit most from using the heart pump. Read More
How to tell whether clinical decision support (CDS) software is exempt from classification as a medical device was the focus of a webinar last week sponsored by the Food and Drug Law Institute. Read More
The Swiss Parliament has cleared the way for legislation to allow non-CE-marked medical devices — including those approved or cleared by the FDA — to be marketed in Switzerland, where only CE-marked medical devices are currently available. Read More
Speakers at a Food and Drug Law Institute virtual meeting on digital health technology last week agreed that a coordinated vulnerability disclosure (CVD) process is needed to address cybersecurity threats to medical devices. Read More
B. Braun Medical’s Space Infusion Pump System wireless devices have earned Underwriter Laboratory (UL) 2900-2-1 Cybersecurity Assurance Program (CAP) certification, a standard supported by the FDA. Read More