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Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC
On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc.  The transaction was only able to gain approval of the Federal Trade Commission (FTC)...
FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement:...
FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of...
Pfizer Australia Announces Deal to Acquire ResApp Health
ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc.  Pfizer agrees it would acquire 100% of the shares for AUD $0.115 /...
Medical Device Cybersecurity Survey Report Released
Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.”  The company’s website states that their “mission is to enable manufacturers and...
Niazi’s Patent Survives on Appeal: Federal Circuit Reverses In Part Lower Court’s Decision
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit...
Becton Dickinson’s PureWick Wins Patent Infringement Suit Against Stryker’s Sage Products Related To Female External Catheters
PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged that Sage Products infringed U.S. Patent Nos. 10,226,376; 10,390,989; 10,376,407,...
Cancer Drug Patent Not Dead Yet
By Alistair J. McIntyre (Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order...
Surgeon wins $20M jury verdict against DePuy Synthes for Infringement of Knee Prosthesis Patents
Rasmussen Instruments, LLC (“Rasmussen”) won a $20M jury verdict against DePuy Synthes (“Depuy”), a part of Johnson & Johnson Medical Devices Companies. Rasmussen asserted Patent Nos. US 9,492,180 (‘180 patent) and US 10,517,583...
Osteoconductive Filament Developed for 3D Printed Implants
“No other application field showcases more the classic advantages of 3D printing, such as individualization or design freedom, than medical technology,” says Marc Knebel, Head of Medical Systems at Evonik....
Federal Circuit Reverses District Court’s Decision Based on On-Sale Bar (Junker v. Medical Components, Inc.)
On February 10, 2022, in Junker v. Medical Components, Inc., the U.S. Court of Appeals for the Federal Circuit reversed the Eastern District of Pennsylvania’s grant of summary judgment of...
Researchers Develop Blood Clot Test Based on Single Drop of Blood
The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a...
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