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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":

Shutdown Will Impact FDA

Knobbe Martens 4 days ago

Written by: Alistair J. McIntyre The looming government shutdown will likely slow the pace of work at the FDA. The federal government... Read More »

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Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers

Knobbe Martens 5 days ago

Written by: Kregg Koch For good reasons, including product safety, quality assurance, development of delivery procedures and instructions... Read More »

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Prosecution History May Support a Motivation to Combine

Knobbe Martens Sep 22, 2023

Written by: Rhett D. Ramsey & Jacob R. Rosenbaum Elekta Limited v. Zap Surgical Systems, Inc. Before: Reyna, Stoll, and... Read More »

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FDA Releases Draft Guidances on 510(k) Submissions

Knobbe Martens Sep 19, 2023

Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft... Read More »

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Medtronic Sued for Allegedly Sharing Health Info With Google

Knobbe Martens Sep 8, 2023

Written by: Eric Wittgrove Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class... Read More »

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FDA Issues Updated Informed Consent Guidance for Clinical Investigations

Knobbe Martens Sep 7, 2023

Written by: Nima Zargari, Ph.D. On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on... Read More »

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Venture Capitalist Funding in Medtech Increasing

Knobbe Martens Sep 5, 2023

Written by: Christopher L. Lewis Recent reports, including one by PitchBook, indicate that both venture capitalist funding for... Read More »

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Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

Knobbe Martens Aug 21, 2023

Written by: Kenneth O. Aruda, Ph.D. Software is increasingly used as a medical device, transforming the healthcare industry with the... Read More »

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FDA Statements and Patent Disclosures

Knobbe Martens Aug 11, 2023

Written by: Philip M. Nelson Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve... Read More »

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IPR Petitioners Must Be Permitted to Respond to Claim Constructions First Proposed in Patent Owner Response

Knobbe Martens Aug 9, 2023

Written by: Joshua C. Loader & Justin J. Gillett AXONICS, INC. v. MEDTRONIC, INC. Before Dyk, Lourie, and Taranto. Appeal... Read More »

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FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder

Knobbe Martens Aug 7, 2023

Written by: Joshua C. Loader The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ... Read More »

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FDA Updates Medical Device Shortages List

Knobbe Martens Jul 27, 2023

Written by: Arash Pia The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory... Read More »

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FDA on Pace for a Record Number of Breakthrough Devices in 2023

Knobbe Martens Jul 21, 2023

Written by: Zachary B. Messick The FDA implemented the breakthrough device program in 2015. The program was designed to... Read More »

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Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.

Knobbe Martens Jul 19, 2023

Written by: Rory R. Lootsma Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel... Read More »

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Is FDA Approval for Renal Denervation on the Horizon?

Knobbe Martens Jul 7, 2023

Written by: Michael R. Christensen On August 22-23, 2023, the FDA will conduct an Advisory Committee... Read More »

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Presidio Medical Raises $72 Million for ULF Neuromodulation Platform

Knobbe Martens Jul 3, 2023

Written by: Matthew S. Whitehead Presidio Medical, Inc. announced that the company successfully concluded a Series C funding ... Read More »

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Left Atrial Appendage Occlusion Device Maker Conformal Medical Raises $35 Million in Oversubscribed Series D Round

Knobbe Martens Jun 27, 2023

Written by: Tom Cowan On June 5, 2023, Conformal Medical Inc., developer of a left atrial appendage occlusion... Read More »

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FDA Approves Neuralink to Begin Human Trials of Brain Implants

Knobbe Martens Jun 20, 2023

Written by: Mark Rubinshtein, Ph.D. Neuralink, the biotechnology company founded by Elon Musk, has received approval from the... Read More »

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FDA Clears Sonic DL™ for Cardiac MRI Scans

Knobbe Martens Jun 13, 2023

Written by: Julie Kim On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE... Read More »

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Objective Evidence in Determining Obviousness

Knobbe Martens Jun 7, 2023

MEDTRONIC, INC. v. TELEFLEX INNOVATIONS Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board... Read More »

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