Topic:

Device Safety

Latest Headlines

Latest Headlines

FDA finalizes cybersecurity guidance in push to secure devices from hackers

The FDA announced that it has finalized its guidance on managing cybersecurity risks as it aims to protect patient privacy and prevent devices from malfunctioning due to computer viruses.

Endo pays $400M to settle remaining vaginal mesh claims

Endo International is approaching the end of the road in its vaginal mesh saga, agreeing to pay $400 million to settle "substantially all" of the remaining suits related to its vaginal-mesh implants.

Analysts bullish on leadless pacing market, call it a $700M opportunity

Leadless pacemakers are a "game-changing technology" that could eventually grab as much as 40% of the overall pacemaker market, say Leerink Swann equity analysts.

Physicians defend power morcellator devices amid industry fallout

Amid mounting regulatory and industry criticism for gynecological tools used in minimally invasive procedures, physicians continue to defend the devices as a viable surgical option.

The metal-on-metal hip legal saga round one (of 6,000?): J&J vs. Herlihy-Paoli

Johnson & Johnson squared off with aggrieved metal-on-metal hip customer Kathleen Herlihy-Paoli in a case that the plaintiffs says could lead to a $5 billion-plus payout. Herlihy-Paoli's claims that the hips leaked metal into her bloodstream, leading to an infection that required the artificial hip to be removed.  

FDA issues largest one-day recall ever for 233 products

Customed received the most serious recall the FDA hands out--a Class I recall. This recall is the largest across-the-board recall the FDA has ever issued to date, 9 times larger than the previous record holding recall.

Pew report makes recommendations on improving data registries

To improve postmarket monitoring of medical devices, three prominent stakeholders released a report today on the optimal use of medical device data registries to enable postmarket surveillance.

J&J shoring up for latest courtroom battle over all-metal hip implant

Long beleaguered by claims related to defective all-metal hip implants, Johnson & Johnson is shoring up for its latest courtroom battle as the company faces the first trial for one of its artificial hip devices.

Boston Sci gets bad news on four of 23,000+ vaginal mesh lawsuits

Boston Scientific faces more than 23,000 lawsuits over its Pinnacle transvaginal mesh device. Last week it failed to remove four cases from a consolidated multidistrict litigation suit in the U.S. District Court for Western Virginia.

FDA allows Covidien to restart manufacturing of two recalled devices

The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.