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The FDA explains the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirement for a new 510(k) filing, in a final guidance released yesterday — one of six newly released guidances from the agency related to imaging solutions and lasers.
The U.S. Supreme Court has refused to review a $302 million judgment levied against Johnson & Johnson (J&J) by California for misrepresenting the risk of its pelvic mesh products in marketing materials.
President Biden has upheld the U.S. International Trade Commission’s final determination that Apple infringed on AliveCor’s wearable electrocardiogram device, keeping alive a limited exclusion order and a cease and desist order on Apple to cease importing certain versions of its watches.
Having solid design and process verification baked into the product lifecycle is a challenge for devicemakers as it calls for effective collaboration between separate units, according to one medical device quality and regulatory expert.
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.