Device Safety

Latest Headlines

Latest Headlines

Avita snags $8M from BARDA to aid in PMA filing for ReCell

Avita Medical will gain an additional $7.96 million to support its plans for U.S. market approval and launch of ReCell. This money, from the Biomedical Advanced Research and Development Authority, supplements the $53.9 million contract that went through last September.

Intuitive Surgical hid more than 700 injury claims, its liability insurers allege

Intuitive Surgical is still fighting to establish robot-assisted surgery as legitimate. The latest issue has been raised by its own liability insurers, Illinois Union Insurance and Navigators Specialty Insurance. They are alleging in a federal lawsuit that Intuitive Surgical hid cases of patient injury when it was applying for insurance coverage.

FDA approved high-risk women's health devices without proper data: Study

Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.

Langer startup reports data, starts pivotal trial for bioengineered blood vessel for dialysis patients

Bioengineered blood vessels could see an early use aiding hemodialysis patients who have exhausted their vascular access options.

Patients push back at UnitedHealthcare's exclusive insulin pump pact with Medtronic

Tandem Diabetes Care is not the only one up in arms about UnitedHealthcare's recent deal to make Medtronic its sole in-network insulin pump provider. Some patients are also pushing back at the move, saying that the insurer's decision could limit therapeutic options for people with diabetes.

NIH to weigh in on artificial pancreas development at upcoming meeting

Artificial pancreases are moving closer to market and the government wants to weigh in. The National Institutes of Health (NIH) is holding a workshop to discuss the technology and how to make the devices safe and efficient for patients.

California lawmaker calls on FDA to step up oversight amid duodenoscope fallout

Superbug outbreaks tied to duodenoscope devices have caused regulators to step up their oversight of the products. But one lawmaker wants the agency to go even further and is asking Congress to back his efforts.

Harvard team uses bacterial enzyme coating to extend life of implantable devices

The body's response to foreign material--forming blood clots and becoming inflamed--can prevent blood-contacting implants like stents and heart valves from working properly. While the only recourse is to replace the device, Harvard scientists have developed a new biochemical method to coat these devices to preserve their function.

Senator grills Medtronic, FDA over alleged mishandling of Infuse bone graft study data

Medtronic has taken some responsibility for mishandling data from a retrospective chart review of its bone graft, Infuse, after a recent report said that the company allegedly buried side effect reports linked to the product. But Medtronic's response did not appease one lawmaker, who is calling on the company and regulators for more answers.

UPDATED: Medtronic shut down study of Infuse bone graft and tucked away the evidence: Report

Medtronic is coming under fire for shutting down a study of its bone graft, Infuse, and allegedly tucking away the data. A recent report from The Minneapolis Star Tribune said that the company uncovered serious problems linked to the product but didn't immediately tell anyone, which sparked pushback from the government and the public.