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While a panel of US FDA experts agreed that pathogen reduction technology is a promising strategy for reducing blood platelet contaminations, they raised concerns about the cost of implementing the technology. The maker of the technology, Cerus, says the panel was under-briefed and distracted.
2017 was a watershed year in many respects, politically, economically and commercially for many players in the medtech field. Where will the opportunities lie in 2018, will breakthrough medtech innovation still have a place among providers often riding on fumes when it comes to budgets, and is it all as bad as some would make out?
A group of antimicrobial susceptibility test manufacturers are working with US FDA regulators to hasten the clearance process for their products. The agency recent convened a workshop at its Maryland headquarters to help address the issue.
FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.
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- Philippe Sans, Pres.
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