Medical Devices > Nova Content
Written by: Mengmeng Du
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius... Read More »
Written by: Adam G. Copeland
Cleerly, a digital healthcare company offering artificial-intelligence-based software to identify and... Read More »
Written by: Brandon G. Smith
IP rights can be vital to the success of medical device companies. Significant legislative... Read More »
Written by: Raina Patel
The FDA issued a warning letter to Abiomed, for failing to seek approval for... Read More »
Written by: Adam G. Copeland
Enovis Corporation (“Enovis”) announced on September 25, 2023, that it has agreed to... Read More »
Written by: Christian Boettcher
Haemonetics Corporation announced on October 10th that it would be acquiring OpSens... Read More »
Written by: Alistair J. McIntyre
The looming government shutdown will likely slow the pace of work at the FDA. The federal government... Read More »
Written by: Kregg Koch
For good reasons, including product safety, quality assurance, development of delivery procedures and instructions... Read More »
Written by: Rhett D. Ramsey & Jacob R. Rosenbaum
Elekta Limited v. Zap Surgical Systems, Inc.
Before: Reyna, Stoll, and... Read More »
Written by: Paige L. Cappelli
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft... Read More »
Written by: Eric Wittgrove
Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class... Read More »
Written by: Nima Zargari, Ph.D.
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on... Read More »
Written by: Christopher L. Lewis
Recent reports, including one by PitchBook, indicate that both venture capitalist funding for... Read More »
Written by: Kenneth O. Aruda, Ph.D.
Software is increasingly used as a medical device, transforming the healthcare industry with the... Read More »
Written by: Philip M. Nelson
Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve... Read More »
Written by: Joshua C. Loader & Justin J. Gillett
AXONICS, INC. v. MEDTRONIC, INC.
Before Dyk, Lourie, and Taranto. Appeal... Read More »
Written by: Joshua C. Loader
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ... Read More »
Written by: Arash Pia
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory... Read More »
Written by: Zachary B. Messick
The FDA implemented the breakthrough device program in 2015. The program was designed to... Read More »
Written by: Rory R. Lootsma
Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel... Read More »