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AdvaMed, joined by eight health advocacy groups, sent a letter to Congressional committee leaders urging year-end passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which was dropped from the user fee reauthorization package passed Sept. 30.
Roche Diabetes Care has lost its second appeal of the U.S. Patent Office’s (USPTO) rejection of a blood glucose electrochemical sensor as unpatentable.
Three subsidiaries of Johnson & Johnson (J&J) who work in medical robotics have filed a lawsuit in the U.S. District Court in Northern California against Noah Medical and 13 individual defendants, claiming three former employees and 10 others collectively stole 26,000 documents of trade secret materials.
The EU is considering a proposal to delay by several years the compliance deadline for its Medical Device Regulation (MDR) which was to go into effect May 26, 2024, as there are insufficient resources to meet the deadline required by law. Read More
The FDA explores the blurred regulatory line between medical device software and non-device software functions in a new report that concludes the benefits of non-device software outweigh the risks.
In a nod to the increasing development of three-dimensional visualization tools, the FDA has created a new page on its website devoted to listing augmented and virtual reality medical devices.
The FDA published a draft guidance Thursday that lays out a risk-based framework to guide review staff and device manufacturers on what human factors information to include in a marketing submission to the Center for Devices and Radiological Health (CDRH).
To help manufacturers better understand and make use of the FDA’s four-year-old Voluntary Summary Malfunction Reporting (VMSR) program, the agency released draft guidance on Thursday to explain — but not change — the conditions of the VMSR. Read More