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A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
A growing population of heart disease patients coupled with the shift from open surgery to minimally-invasive interventions has brought an influx of activity into the percutaneous ventricular assistance device space, with a variety of innovative solutions.
An industry coalition has petitioned FDA to rescind and repropose its Clinical Decision Support Software guidance. Excerpted from Pathways’ Picks February 8: MEDCAC Meeting, Software Petition, and More.