Senseonics has obtained CE mark approval for its next-generation Eversense E3 continuous glucose monitoring (CGM) System, which can be used for up to six...
The new article provides an overview of the Essential Principles for specific types of medical devices, such as active medical devices, the ones with...
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical...
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical...
Study to support U.S. FDA approval of the novel CLAAS® implant forleft atrial appendage occlusion (LAAO) and stroke prevention
NASHUA, N.H., June 17, 2022...
The article provides an overview of the existing regulatory framework for heater-cooler devices. Table of ContentsThe Food and Drug Administration (FDA or the Agency),...
