Medical Innovation Exchange

implants

Biomedical Implant Design: Researchers Uncover Culprit Behind Rejection

Biomedical Implant Design: Researchers Uncover Culprit Behind Rejection     A significant number of patients receiving biomedical implants, such as breast implants, pacemakers and orthopedic hardware, will experience a foreign body response, or FBR, in which the body encapsulates the implant in scar tissue, necessitating removal of the implant. The reaction is not well understood. However, …

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FDA Issues Three New Draft Guidances on the 510(k) Program

FDA Issues Three New Draft Guidances on the 510(k) Program     On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices while continuing to bring critical devices to patients. The new guidances include: On October …

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