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This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act FDCA, as well as regulatory issues unique to non-US companies.
Vancouver, British Columbia and Minneapolis, Minnesota--(Newsfile Corp. - August 17, 2021) - Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) ("Neovasc" or the "Company") announced today that it has filed a supplement
Share this article Share this article SAN DIEGO, April 6, 2021 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify ® Cervical Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR). "This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfol...
FDA Approves NuVasive's Simplify Disc For Two-Level Cervical Total Disc Replacement WASHINGTON (dpa-AFX) - NuVasive, Inc. (NUVA), Tuesday announced that the NuVasive Simplify Cervical Artificial Disc received approval from the U.S. Food and Drug Administration for two-level cervical total disc replacement. 'This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio,' said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. 'There is immense surgeon excitement for this latest edition...
Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success By Adam Atherton, KEB, LLC The FDA conducts thousands of quality system inspections each year. The FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations here. In this article, I present background and high-level observations on the inspection data over time. My next article will analyze FY2020 data and how it compares to previous years. FDA inspections of medical device quality systems ...