Medical Design & Outsourcing

FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices

RAPID could enable Medicare coverage and payment as soon as two months after FDA approval, compared to a year or more with ...
RAPS

FDA Releases Draft Guidance on Design of Home Use Medical Devices

The US Food and Drug Administration (FDA) has released a new medical device draft guidance intended to assist manufacturers in designing and developing devices used by a patient in their own ...
Medical Device and Diagnostic Industry (MD+DI)

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
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 ...