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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.
The patient who develops a knee implant infection is likely to face several repeat surgeries within five years, during which the surgeon enters the joint to aggressively debride the implant and administer antibiotics, and, frequently, to remove the implant. Solenic offers a repeatable, noninvasive method of infection control through the application of thermal energy generated by alternating magnetic fields.
FDA will hold a meeting in early August to discuss recommendations for a renewed user fee program. Excerpted from Pathways’ Picks June 11: MDUFA Meeting, Companion Dx 510(k)s, Next-Gen Sequencing in China, and More.