271 results

• Impella Heart Pump Cybersecurity Risks Result in FDA Recall Warning

  October 13, 2025

  Michael Adams

  Federal regulators have issued an early warning over a cybersecurity flaw in certain Automated Impella Controllers that, if exploited, could pose life-threatening risks to patients.

• Non-Hodgkin’s Lymphoma Lawsuit Over Ethylene Oxide Exposure Results in $20M Verdict Against C.R. Bard

  May 8, 2025

  Irvin Jackson

  A federal judge has declared a mistrial over the punitive damages phase of an ethylene oxide cancer lawsuit against C.R. Bard after a jury awarded the plaintiff $70 million in compensatory and punitive damages.

• Medical Device Manufacturers Often Fail To Submit Timely Adverse Event Reports to FDA: Study

  March 19, 2025

  Martha Garcia

  The findings of a new study indicate that medical device manufacturers turn in a third of all adverse patient event reports later than legally required.

• FDA Proposes New Guidance To Address Pulse Oximeter Inaccuracies Due to Skin Tone

  January 9, 2025

  Martha Garcia

  Federal regulators have put forward new draft guidelines for ensuring the accuracy of pulse oximeters, which can perform poorly on darker skin tones, resulting in patients not receiving life-saving care.

• FDA Report Details How Agency Made Medical Devices Safer in 2023

  April 22, 2024

  Martha Garcia

  An FDA report highlights improvements in medical device recalls, post-marketing surveillance and manufacturing quality in 2023.

• FDA to Hold Public Hearing on Addressing Pulse Oximeter Inaccuracies

  November 27, 2023

  Martha Garcia

  The FDA is investigating the safety and accuracy of pulse oximeters for patients of different races and ethnicities with darker skin pigmentation.

• FDA Finds No Risk of Death Linked to Paclitaxel-Coated Balloons and Stents

  July 12, 2023

  Stephanie Yanovich

  The FDA has reversed its opinion on paclitaxel-coated balloons and stents, saying they no longer believe the implants increase the risk of death for patients.

• FDA Issues Letter To Doctors About Issues with NuVasive Precice Limb-Lengthening Devices

  June 29, 2023

  Martha Garcia

  The FDA is updating warnings about problems with NuVasive Precice limb-lengthening implants following past concerns over biocompatibility.

• FDA Warns of Cybersecurity Vulnerabilities in Certain DNA Sequencing Devices

  May 1, 2023

  Stephanie Yanovich

• Coolsculpting Side Effects Cause Disfiguring PAH Complications For Some Users: Report

  April 21, 2023

  Irvin Jackson

  A New York Times report warns of high rates of deformities and other side effects of the CoolSculpting fat-freezing procedure.