FDA and CMS outline new Medicare coverage pathway for medical device access

The agencies’ initiative is intended to speed up the processes involved in medical devices’ securing Medicare coverage once ...

CMS and FDA launch RAPID Medicare coverage pathway for devices

The RAPID pathway could cut the wait for Medicare coverage from over a year to about 2 months after FDA market authorization ...
Becker's Hospital Review

CMS, FDA launch pathway to speed device coverage

CMS FDA launch pathway expedites Medicare coverage for breakthrough medical devices, enabling payment within two months of FDA authorization.
American Hospital Association

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to ...
Regulatory Affairs Professionals Society

MedCon: FDA sees uptick in class I recalls in 2025 as it tackles resourcing issues

The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
MedTech Dive

CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class ...
MobiHealthNews

uChek app is currently FDA registered as Class I device

Following MobiHealthNews' coverage of the rare action that FDA took last week by sending a medical app developer an "It has come to our attention" letter that instructs it to seek 510(k) clearance for ...
WHNT

FDA issues Class 1 recall on tomatoes sold in 3 states, warns of ‘serious adverse health consequences or death’

TENNESSEE (WHNT) — The Federal Drug Administration announced two different tomato recalls affecting 14 states for the possible contamination of Salmonella at the start of May. Both are now classified ...