Industry Veteran Lands At NESTcc
The Medical Device Innovation Consortium has chosen industry veteran Simon Mason to lead the National Evaluation System for health Technology Coordinating Center, an MDIC initiative to advance the use of real-world evidence in regulatory approvals.
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Pilot Of New US Evaluation System Will Include At Least Two Devices
New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.
News We’re Watching: Two Join Illumina Board, FDA Plans Health Equity Meeting, Pre-Eclampsia Test Cleared
This week, Illumina’s board added two independent members; the VA and the FDA agreed to collaborate on supply chain issues; and Think Surgical, Thermo Fisher Scientific and Blue Earth all landed FDA clearances.
AdvaMed Offers Plan To Strengthen Medtech Supply Chain
Medtech trade group AdvaMed is offering a list of recommendations to beef up the nation’s medical technology supply chain. Public-private partnerships are central to the group’s plan.