‘Living With Covid’ Report Calls For National Testing Infrastructure
The post-pandemic roadmap estimates that getting the US ready for further spikes of COVID-19 and other respiratory illnesses would cost $100bn in the first year.
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News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.
FDA Tweaks Q-Sub Meeting Guidance
The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.
MDSAP Audit Allows Emerging Firm To Expand Internationally
Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight.