Topic:

Device Safety

Latest Headlines

Latest Headlines

Boston Scientific ordered to hand over $18.5M in vaginal mesh litigation

Less than a week after Boston Scientific lost its second courtroom battle over vaginal mesh implants, a federal jury ordered the company to pay $18.5 million in damages to four women who claimed the devices caused them constant pain and injuries.

Power morcellation ban unlikely, but other FDA restrictions coming soon

The doctor who brought the cancer risks posed by power morcellation to the attention of the public and the FDA protested what he described as "imminent plans to use legal mechanisms to functionally institute a 'registry of outcomes' or a 'probationary period' in order to avoid banning power morcellators from the marketplace," in an email to Commissioner Hamburg, various U.S. senators, White House officials and others obtained by FierceMedicalDevices.

Dozens of lawsuits filed in growing counterfeit spinal screw implant scandal

More than two dozen lawsuits related to the distribution and use of counterfeit spinal screws and hardware implanted in patients were filed Friday in Los Angeles Superior Court, claiming a former hospital executive and his business partners were in on the conspiracy.

J&J prepares to face ruling in first Pinnacle hip implant trial

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.

Department of Homeland Security to weigh in on device cybersecurity

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.

Report warns of cyberattacks against medical devices to extort money

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.

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.