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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."

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New Study Validates Rigorous Safety Measures Needed To Reduce Mercury Exposure During Dental Amalgam Filling Removal

"For decades, our non-profit organization has been concerned about this issue and collected research about amalgam fillings, all of which contain approximately 50% mercury, a known neurotoxin," explains IAOMT President Michael Rehme, DDS, NMD.  "Based on this science, we have strongly recommended that safety measures be enacted for dental procedures involving these silver-colored fillings, and we have also intensely advocated for the end of dental amalgam usage."