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In a 537-3 vote, the European Parliament passed an amendment to extend the transition period for manufacturers to comply with the Medical Devices Regulation (MDR) to prevent shortages of medical devices.
The FDA hopes to see the new Congress reconsider the VALID Act — which failed to become law last year — for its ability to create transparency for in vitro clinical tests and improve emergency preparedness, said Elizabeth Hellebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiologic Health.
An antitrust lawsuit filed Tuesday by Applied Medical Resources claims Medtronic uses anticompetitive bundling agreements to “illegally block” competition in the advanced bipolar energy device market.
Patients who are near metallic devices, objects or implants should stop using the mask and consult a physician to determine if another mask can be used, the company said.
Johnson & Johnson subsidiary Ethicon has agreed to pay the state of Kentucky $9.9 million to resolve allegations of deceptive marketing practices for Ethicon’s pelvic mesh surgical devices.
Just a day before a jury trial was set to begin, Alcon agreed to pay $199 million to J&J Surgical Vision to settle their intellectual property rights lawsuit over J&J’s laser-assisted cataract surgery software.
The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products —whether a drug, biologic product or device — in a new draft guidance released Friday.