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Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers

Written by: Kregg Koch For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical...

Fresh From the Bench: Latest Precedential Patent Cases

CASE OF THE WEEK Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case...

Enter TitleFederal Circuit Revisits Standard for Enablement of Antibody Claims

Written by: Ashley C. Morales & Joseph Mallon, Ph.D. In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision...

Fresh From the Bench: Latest Precedential Patent Cases

CASE OF THE WEEK Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc., Appeal Nos. 2021-2299, -2338 (Fed. Cir. Sept. 15, 2023) In a decade-old case that has ...

Prosecution History May Support a Motivation to Combine

Written by: Rhett D. Ramsey & Jacob R. Rosenbaum Elekta Limited v. Zap Surgical Systems, Inc. Before: Reyna, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board. ...

Landmark CAFC Cases in Patent Law: Shaping the Future of Innovation

In the ever-evolving landscape of patent law, the Court of Appeals for the Federal Circuit (CAFC) has played a pivotal role in shaping the rules and precedents governing intellectual...

Feed tagged as "medical devices":
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 »
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS Before Moore, Lourie, and Dyk.  Appeal from the Patent Trial and Appeal Board... Read More »
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