FDA Still Lags In Cybersecurity Game, Expert Says
This article was originally published in The Gray Sheet
A cybersecurity expert who works with hospitals to protect systems and devices from network attacks welcomes FDA's efforts to boost regulations around medical device cybersecurity, but says the agency should have made more of a push seven years ago when Microsoft announced it was no longer going to support Windows XP and Windows 7.
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Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
The series D financing will support the expansion of Everlywell’s consumer lab testing and digital health businesses.
New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.