In this week’s roundup: Possible action to ease pressure from the May 2022 IVD Regulation deadline coming, Biden to rescind Trump guidance policies, FDA upclassifies surgical staplers, Germany reports on digital health reimbursement reviews, Mexico appoints a new commission head, and more from the US, Europe and around the world.
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Though congenital heart defects are a leading cause of childhood fatalities, there are no prosthetic valves for transcatheter use in young children. PolyVascular seeks to change this with a polymer-based transcatheter valve that could spare patients one or more open surgeries.
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The top five Market Pathways articles posted in September to MyStrategist.com, chosen by readers and editors, include CMS’ proposed repeal of the MCIT rule, getting reimbursement for AI tech, Doc Depot, our Q&A with MDIC’s new VP of Health Economics & Patient Value, and robust regulatory activity in Asia.