CMS and FDA Launch RAPID Pathway to Speed Access to Breakthrough Medical Devices
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
The deal adds inspection, calibration, and repair services for outpatient and clinical settings as demand for reliable equipment support grows.
Analysis of 21 models shows gaps in early-stage decision-making, reinforcing need for clinician oversight as AI tools enter care settings.
The acquisition includes exclusive rights to the FDA-cleared xvision Spine System, which uses augmented reality for surgical navigation.