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Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices
Written by: Paige L. Cappelli The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC.... Read More
FDA Issues Warning About Fraudulent and Unreliable Laboratory Data
Written by: Eric Wittgrove                                  ... Read More
Knobbe Martens
Jun 15, 2018
Featured
First Prosthetic Iris Approved
On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the... Read More
Knobbe Martens
Feb 4, 2018
First-Ever De Novo Clearance by FDA’s Orthopedic Branch
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the... Read More
Knobbe Martens
Feb 4, 2018
Featured
Medtronic Pain Management Device Approved by FDA
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable... Read More
Knobbe Martens
Feb 3, 2018
FDA Approves Prickless Glucose Monitoring System
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes... Read More