30 results

• FDA Raising Questions About Safety Of Nitinol, Alloy Used In Essure And Other Medical Implants

  April 19, 2019

  Irvin Jackson

  The FDA has issued a new draft guidance on how manufacturers should test devices made with nitinol, a metal alloy suspected of potentially causing allergic reactions in humans.

• Medical Equipment Running Old Software Is Vulnerable To Hackers: Report

  March 19, 2019

  Russell Maas

  Cybersecurity experts warn that old software used in medical equipment makes them vulnerable to hacking.

• Major Changes Coming To Controversial 510(K) Medical Device Approval Process, FDA Officials Say

  December 5, 2018

  Irvin Jackson

  The FDA is considering changes to its highly criticized 510(k) medical device approval program.

• The Implant Files: International Investigation Exposes Rampant Safety Problems With Medical Devices

  November 29, 2018

  Irvin Jackson

  A worldwide investigation raises concerns about the state of medical devices, how they are approved, and what happens when they are deemed to be unsafe.

• FDA Pediatric Medical Device Meeting Set To Discuss Getting New Devices To Market

  July 6, 2018

  Russell Maas

  The FDA will hold a meeting next month to address the development of pediatric medical devices, which experts say has fallen behind the development of devices for adults.

• FDA Moves Forward With Plans To Make Medical Device Approvals Easier, Faster, Despite Concerns

  October 27, 2017

  Irvin Jackson

  The FDA has announced new plans to speed up the approval of new medical devices, raising some concerns about patient safety.

• FDA Approval Requirements Removed For 1,000 Low-Risk Medical Devices

  July 12, 2017

  Irvin Jackson

  The FDA has published a list of more than 1,000 medical devices that are now exempt from premarket approval requirements.

• FDA Seeks To Ease Approval Requirements for Moderate Risk Medical Devices

  March 27, 2017

  Irvin Jackson

  The FDA is considering further reductions in requirements for moderate-risk medical devices to hit the market, following passage of the 21st Century Cures Act late last year, which some say would remove virtually all oversight for some devices before they are used on patients.

• Active Surveillance Of Medical Devices May Be More Reliable Than Adverse Event Reports: Study

  February 2, 2017

  Irvin Jackson

  A new study suggests that active surveillance of medical devices is far more effective than the current adverse event reporting system used to detect safety problems.

• New Reporting Rules To Affect All FDA-Regulated Drugs and Device Clinical Trials

  September 23, 2016

  Irvin Jackson

  Federal regulators have finalized broad requirements on the release of information on clinical trials affecting products regulated by the FDA or which have received federal funding.