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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.
Perfuze announced that its Millipede 088 Access Catheter — which gained Breakthrough Device status from the FDA in 2019 — has now been cleared by the agency to treat acute ischemic stroke and has been used successfully in surgeries at two U.S. hospitals.
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.
The FDA issued a warning letter to Wintech Medipro for marketing its surgical masks without a premarket application or investigational device exemption and for several other lapses observed during an inspection of the company’s Katy, Texas facility.
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.