Friday, November 22, 2019
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    5/7/19: FDA Issues Alert on Potential Premature Battery Depletion of Certain Medtronic Implantable Pacemakers: Approves Related Dnhancements to Device

    The FDA has issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients.

    FDA Proposes Improvements to the De Novo Pathway for Novel Medical Devices to Advance Safe, Effective, and Innovative Treatments for Patients

    12/4/18: De Novo Classification Proposed Rule builds on FDA’s earlier work to provide structure, clarity, & transparency to the De Novo classification pathway.

    FDA Permits Marketing of Two Devices That Detect Parathyroid Tissue in Real-Time During Surgery

    11/4/18: "For some patients with parathyroid disease, treatment may mean a surgical procedure," said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health. "Real-time identification of parathyroid tissue during surgery can provide surgeons with valuable information to help preserve healthy tissue or to remove diseased tissue."