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The new RAPID pathway promises what medtech has chased for over a decade: device authorization and Medicare coverage in unison. But unease about narrow eligibility, an unproven CMS resource base, and the prospect of an unpredictably heavier premarket burden has industry wondering whether RAPID is a real fix or just a new acronym.
This month, consumer tech giants acquire or partner to put core skill sets to use for medical applications; two private equity deals signal what's hot; and Curium, curiously, creates a radiopharmaceuticals giant.
The country amends its regulations to further rely on EU CE marks, and makes other simplifications. Excerpted from Pathways Picks August 26: India Harmonization, Digital Health Updates, FDA Home Challenge, and More.