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Latest From Elizabeth Orr
The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.
The justices struck down an appeals court ruling that a single device component could count as a “substantial portion” under patent infringement laws.
The recall involves 3,662 artificial shoulders manufactured between 2008 and 2011, which have a higher fracture risk than depicted in labeling.
Claret Medical’s Sentinel embolic protection device for transcatheter aortic valve replacement is set to go before US FDA’s Circulatory System Devices Panel on Feb. 23. Trials found the de novo device is safe, but the agency has some concerns that a primary efficacy endpoint was missed.
Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.
A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.