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Novarad’s 3D augmented reality surgical navigation system VisAR has received 510(k) clearance from the FDA for precision-guided spine surgery. Read More
The FDA’s Center for Device and Radiological Health (CDRH) has released final guidance on what technical performance assessment and user information should be included in a premarket submission for radiological devices with quantitative imaging functions. Read More
Cyberattacks have become a routine occurrence, prompting radical changes in the way device manufacturers think about the problem, all the way back to the design stage, according to a panel discussion Tuesday at the Food and Drug Law Institute’s annual conference. Read More
The Verifying Accurate Leading-edge IVCT Development (VALID) Act was included as part of user fee reauthorization legislation that passed through the Senate Committee on Health, Education, Labor and Pensions (HELP) Tuesday in a 13 to 9 vote. Read More