4/27/2015 3:15:00 PM
The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.
4/23/2015 12:30:00 PM
On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the U.S. Food and Drug Administration.
4/17/2015 5:15:00 PM
The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.