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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...
FDA Proposes Changes to Medical Device Quality Regulations
The U.S. Food and Drug Administration (FDA)  published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation.  According to the FDA, the proposed rule change...
FDA: Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19
According to the FDA’s Center for Devices and Radiological Health (CDRH) Annual Report, in addition to its significant efforts to fast track the approval of COVID-19 related devices, the CDRH...
Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN
Medtronic  announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic...
First-in-Human Porcine Heart Transplant Performed
Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred to as “xenotransplantation.”  The patient, 57 year old...
Acquisition of BK Medical Expands GE Healthcare’s Precision Health Presence
GE Healthcare announced on December 21, 2021, that it has completed the $1.45 billion acquisition of BK Medical from Altaris Capital Partners.  According to the press release, the acquisition expands...
Baxter Completes $10B+ Acquisition of Hillrom
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for...
Two Drugs Recalled Due to Manufacturing Issues
By Mark Rubinshtein (December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. Edge...
FDA Breakthrough Device Designation for Biology-Guided Radiotherapy (“BgRT”) Device
On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for...
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