41 results

• Medtronic Spinal Cord Stimulator Lawsuit Alleges Device Worsened Pain

  April 30, 2025

  Michael Adams

  Federal regulators accepted hundreds of changes to a Medtronic SCS device without reexamining it for premarket approval, which eventually led a Kentucky woman to experience multiple injuries.

• FDA Announces Plan to Phase-Out of Artificial Food Dyes

  April 28, 2025

  Michael Adams

  Federal regulators have announced plans to remove all petroleum-based food dyes from U.S. products by the end of 2026, which is even faster than originally anticipated.

• Flavored Vape Restrictions Upheld by Supreme Court

  April 3, 2025

  Michael Adams

  The U.S. Supreme Court has upheld an FDA decision to block the marketing and sale of certain flavored e-cigarette products, targeted at minors.

• Philips X-Ray Table Recall Issued After Injuries Reported

  March 4, 2025

  Darian Hauf

  Federal health officials are directing healthcare providers to updated guidelines for using Allura and Azurion X-ray table systems after multiple injury reports.

• Gardasil Lawsuit Payouts Could Raise Conflict-of-Interest Questions for RFK, Jr. as HHS Secretary: Report

  January 27, 2025

  Irvin Jackson

  Concerns about Robert F. Kennedy Jr.'s nomination to lead DHHS has raised questions about his financial interests in a large number of Gardasil lawsuits being pursued against Merck & Co. by users of the HPV vaccine.

• Warnings and Communications Paused for U.S. Health Agencies Until Feb. 1

  January 24, 2025

  Martha Garcia

  The gag order includes all public communications from federal agencies under the Department of Health and Human Services, including the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health.

• Problems With Recalled Philips Heart Monitoring Application Linked to Injuries, Deaths

  January 14, 2025

  Martha Garcia

  Federal regulators have announced a faulty software program designed to be used with Philips medical devices is at the center of a class I recall, which has led to at least 100 patient injuries and two deaths.

• Problems With Recalled BioZorb Markers Could Cause Severe Injury or Death, FDA Warns

  December 19, 2024

  Irvin Jackson

  The FDA is giving a recent BioZorb marker recall a class I designation, indicating the federal agency believes problems with the device, implanted to assist in targeted therapy in breast cancer patients, can cause serious injuries and potentially death.

• FDA Warns About Failure Risks with Fresenius Ivenix Infusion Pumps

  December 12, 2024

  Martha Garcia

  An alert has been issued about problems with Fresenius Ivenix Infusion pumps, due to a risk that the devices may fail to deliver life-saving drugs to patients.

• Tattoo Ink Bacterial Infection Risks Addressed by FDA

  October 30, 2024

  Darian Hauf

  New federal guidelines have been introduced to help reduce the risk of tattoo ink becoming contaminated by unsanitary equipment or manufacturing environments.