Device Safety

Latest Headlines

Latest Headlines

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.

FDA recalls 440,000+ equipment drapes used by Intuitive Surgical

The FDA recalled 442,475 of Microtek Medical's equipment drapes that are used "to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting."

U.S. health insurers consider new curbs on morcellators amid regulatory pushback

U.S. health insurers are joining a swelling chorus of discontent over power morcellators, limiting the products or considering new restrictions a year after the FDA warned against using the devices in certain gynecological procedures.

FDA to investigate Bayer's birth control device after allegations of fraud during clinical trial

The FDA has agreed to investigate Bayer's Essure birth control device, following complaints of fraud during the clinical trial and dangerous side effects.