Device Safety

Latest Headlines

Latest Headlines

Issue that led to halt of St. Jude TAVR trial no cause for concern, EuroPCR experts say

St. Jude Medical suffered a rare withdrawal of the CE mark of its Portico transaortic aortic valve replacement last year and had to suspend its U.S. clinical trial for FDA approval. Now new data released from three studies at the annual EuroPCR conference in Paris should help St. Jude convince the FDA to resume that trial.

FDA reveals it's received 142 reports of contaminated duodenoscopes since 2010

In preparation for an upcoming meeting on duodenoscope safety, the FDA revealed it's received 142 reports of contaminated duodenoscopes since 2010.

Aetna curbs power morcellator coverage amid industry fallout

As the industry and regulators respond to public outcry over power morcellators used in minimally invasive gynecological procedures, one of the U.S.'s largest health insurers is curtailing its coverage of the device.

UPDATED: Under FDA investigation, Bayer releases new data on Essure contraceptive with a positive twist

Under investigation by the FDA following claims of dangerous side effects and fraudulent clinical trial data, Bayer has released new data from a long-term study the German drugmaker says supports the safety and effectiveness of its Essure contraceptive inserts.

Telesurgery raises cybersecurity concerns

Someday, robots may perform surgery on patients, especially in areas where trained doctors are lacking. They would be controlled by surgeons from a distance.

Low-cost smart syringe shoots for reduced disease transmission

As the industry turns its attention to smart needles that help reduce disease transmission, one device offers a more affordable option: the K1 auto-disable syringe. The K1 costs between four and 5 cents, whereas traditional syringes can run anywhere from three to four cents and single-use syringes can cost double that.

Medtronic facing new wrongful death lawsuit over failed insulin pump in wake of 2009 recall

The executor of the will of a New Jersey man who died of a night-time diabetes attack is suing Medtronic for the alleged failure of its MiniMed insulin pump and infusion set.

Study finds Boston Scientific's S-ICD has sterling safety profile, quarterly sales exceed $100M

Boston Scientific played up a data registry study in the Journal of the American College of Cardiology demonstrating the safety of its subcutaneous implantable defibrillator, which is the only device of its kind without leads that come into direct contact with the heart.

Citing power morcellator safety scare, insurance lobby calls for tougher regulation of devices

America's Health Insurance Plans says the danger posed by cancer-spreading power morcellation points to the need for broader regulatory reform in a letter to Sen. Robert Casey (D-PA) noting "the serious gaps in the current approval and post monitoring process for medical devices."

FDA recalls fall more than 50% in Q1 2015 after reaching record high in 2014

There were 426 medical device recalls in the first quarter of this year, according to FDA's recall database, down from a record high of 968 in Q4 2014.