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