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 »