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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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: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
The US FDA has cleared an AI software diagnostic product from an Israeli firm designed to detect a type of fatty liver, which is often an early indication of serious liver disease.