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Latest From Elizabeth Orr
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.
The US FDA released one device-related close-out letter in November.
A device newly approved by the US FDA will allow physicians to insert ear tubes to treat recurrent ear infections in the office, eliminating the risks of general anesthesia. The Tubes Under Local Anesthesia (Tula) System was reviewed via the agency’s breakthrough device pathway.
Medtronic has announced a safety issue in its popular MiniMed 600 series of insulin pumps. The devices may under- or over-deliver insulin if a ring component of the device cracks or breaks, potentially causing serious health issues. The company says the issue doesn’t amount to a recall, however.
Enforcement of the False Claims Act is always a hot-button topic for industry. That’s because fines for FCA violations can be costly, reaching into the billions of dollars. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Elizabeth Orr about some of the more important FCA cases from 2019.