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Stanford Study Highlights Need For Transitional Reimbursement Pathway

 
• By Hannah Daniel

Results of a study of FDA and CMS data found that 44% of 64 new devices were granted some kind of Medicare coverage within 5 years of FDA approval of clearance.

A stethescope, calculator, and dollar bills over a health insurance form.
• Source: Shutterstock

A study of Medicare data and US Food and Drug Administration authorizations found that the lengthy coverage period for newly cleared or approved medical devices highlights the need for a new "transitional coverage" pathway.

Zachary Sexton, a bioengineering graduate student at Stanford University, led a group at Stanford that analyzed 281 devices authorized by...

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First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
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More from Policy & Regulation

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
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Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.