Medical Devices > Nova Content
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices... Read More »
AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC.,
Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board... Read More »
ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. ... Read More »
Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and... Read More »
NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC.
Before Taranto, Bryson, and Stoll. Appeal from the U.S. District Court for ... Read More »
ROCHE DIAGNOSTICS CORPORATION v. MESO SCALE DIAGNOSTICS, LLC
Before Newman, Prost, and Taranto. Appeal from the U.S. District Court... Read More »
Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order... Read More »
Rasmussen Instruments, LLC (“Rasmussen”) won a $20M jury verdict against DePuy Synthes (“Depuy”), a... Read More »
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... Read More »
The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood... Read More »
The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control... Read More »
LARRY G. JUNKER V. MEDICAL COMPONENTS, INC.
Before Dyk, Reyna, and Stoll. Appeal from United States District Court for the Eastern District of Pennsylvania... Read More »
In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has... Read More »
BLEPHEX, LLC. v. MYCO INDUSTRIES, INC.
Before: Moore, Schall, and O’Malley. Appeal from the Eastern District of Michigan.
Summary: Conclusory statements ... Read More »
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from... Read More »
Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred... Read More »
GE Healthcare announced on December 21, 2021, that it has completed the $1.45 billion acquisition of BK Medical from Altaris Capital... Read More »
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021... Read More »
(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... Read More »
On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has... Read More »