Johnson & Johnson is facing grave allegations that the company, in an effort to preserve billions in profit, ignored overwhelming evidence that its Pinnacle hip implants were highly dangerous.
Amid growing industry concern over the cybersecurity of medical devices, the U.S. government is weighing in on the issue and investigating two dozen cases of suspected cybersecurity flaws in devices and hospital equipment.
Medical device cyber security concerns were aroused when a baddie in the show Homeland hacked into the vice president's pacemaker and initiated a fatal heart attack. Now, a report by the European Cybercrime Centre warns of the real rise of similar "ransomware" attacks, although financial gain, not murder, would be the goal.
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.