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Patexia Interest Groups

Medical Regulation > Nova Content

Written by: Makoto Tsunozaki, Ph.D. & Agnes Juang, Ph.D. On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and... Read More »
Written by: Douglas W. Crandell, Ph.D. and Joseph Mallon, Ph.D. A recent article[1] authored by Haider J. Warraich, MD[2]; Troy... Read More »
Written by: Susan M. Janicki, Ph.D. & Robert J. Hilton, Ph.D. On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S... Read More »
Written by: Raina Patel The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to... Read More »
Written by: Alistair J. McIntyre The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical ... Read More »
Written by: Makoto Tsunozaki, Ph.D. & Jason J. Jardine On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a... Read More »
Written by: Makoto Tsunozaki, Ph.D. & Jason J. Jardine On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a... Read More »
Written by: Alistair J. McIntyre & Agnes Juang, Ph.D. On August 19, 2024, the Association for Molecular Pathology (AMP) sued the... Read More »
Written by: Zachary B. Messick On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and Radiological Health... Read More »
Written by: Ari Feinstein & Jane Dai, Ph.D. As we previously discussed, on November 7, 2023, the Federal Trade Commission... Read More »
Written by: Ashley C. Morales & Michael L. Fuller On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to... Read More »
Written by: Brianne M. Kingery & Jason J. Jardine On June 4, 2024, a panel of experts advising the Food and Drug Administration... Read More »
Written by: Sumaia Tabassum Profound Medical (Nasdaq: PROF) has received FDA 510(k) clearance for its second AI model aimed at... Read More »
Written by: Alistair J. McIntyre & Eric Furman, Ph.D. On April 29, 2023, the FDA announced a final rule on regulation of... Read More »
Written by: Phillip J. Minnick, Ph.D. Medical devices that contact the human body undergo biocompatibility safety assessments prior to ... Read More »
Written by: Christian Boettcher Orthobond received on April 5th de novo approval for the company’s spinal... Read More »
Written by: Ari Feinstein & Jane Dai, Ph.D. As we recently discussed, the Federal Trade Commission (“FTC”) sent... Read More »
Written by: Paige L. Cappelli The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in... Read More »
Written by: Eric Wittgrove                              ... Read More »
Written by: Ashley C. Morales & Jane Dai, Ph.D. On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new... Read More »
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