Mechanical Engineering > Nova Content
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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ...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 »
Written by: Michael R. Christensen
On August 22-23, 2023, the FDA will conduct an Advisory Committee... Read More »
Written by: Matthew S. Whitehead
Presidio Medical, Inc. announced that the company successfully concluded a Series C funding ... Read More »
Written by: Tom Cowan
On June 5, 2023, Conformal Medical Inc., developer of a left atrial appendage occlusion... Read More »
Written by: Mark Rubinshtein, Ph.D.
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the... Read More »
Written by: Julie Kim
On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE... Read More »