New and Improved: The Latest Research in Disease Screening
New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes
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How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
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FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
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New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
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