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Latest From Sue Darcey
FDA approved a PMA supplement to remotely program sessions for Cochlear Americas' Nucleus Cochlear Implant System, heralding the feature as the first programming telehealth option for the hearing implants.
Medical device firms will benefit from a Republican tax bill that has passed the full US House and a key Senate committee. The bill lowers the corporate tax rate to 20% from a maximum of 35%, treats foreign-earned intangible income at a favorably low rate of 12.5%, and permits tax-free transfers of intangible corporate property, such as patents, from foreign firms to US parents.
US FDA's device center has made some clarifications to the way it would like to see sponsors directly mark medical devices intended to be reprocessed and reused, and it has beefed up its preferred approach to Unique Device Identification labeling in a final guidance on direct UDI marking released Nov. 16.
FDA used its de novo pathway to clear Innovative Health Solution's NSS-2 Bridge – the first device for use in helping to reduce the symptoms of opioid withdrawal – as a class II device.
US CMS added a telemedicine code, finalized payments for clinical labs, and gave more time for physicians to adapt to its Medicare appropriate-use criteria (AUC) program for advanced diagnostic imaging, as part of its recently released physician fee schedule for 2018.
ECRI Institute's latest annual top-10 list of "health technology hazards" list names "ransomware and other cybersecurity threats" as the number-one hazard. In fact, several items on the 2018 list point to safety risks emanating from the "digital aspects" of patient care and hospital operations.