John Leppard with Washington Analysis says the Medicare agency’s recent delay of the MCIT breakthrough devices rule until mid-December suggests the CMS will likely scrap it altogether and start from scratch.
While the US Centers for Medicare and Medicaid Services has postponed implementing the Medicare Coverage of Innovative Technology (MCIT) rule until at least December, a health analyst says concerns raised by the agency mean it likely will need to be revoked and rewritten.
After initially halting MCIT from going into effect in March, the CMS announced on 14 May that it was further delaying the rule until at least 15 December to give...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
