The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination (see also Infusion Pumps).Baxter is responsible for recalling as many as 200,000 CVIP [...]
The U.S. Food and Drug Administration announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage, age-related macular degeneration (AMD) (see also Epithelial Cells).Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more [...]
FDA NEWS RELEASEFDA Issues Requirements for Baxter Healthcare Infusion Pump Recall Company must provide transition guide for facilities using Colleague infusion pumpsThe U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with [...]
Company must provide transition guide for facilities using Colleague infusion pumpsSILVER SPRING, Md., July 13 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement [...]
Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical practice and for patients [...]
Device designed to help those with end-stage, age-related macular degenerationSILVER SPRING, Md., July 6 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage, age-related macular degeneration (AMD).(Logo: (Logo: Surgically implanted in one eye, the IMT is a small [...]
FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD PatientsDevice designed to help those with end-stage, age-related macular degenerationSILVER SPRING, Md., July 6 The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage, age-related macular degeneration (AMD).Surgically implanted [...]
WASHINGTON, July 6 The U.S. Department of Health and Human Services’ Food and Drug Administration issued the following news release:The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).Surgically implanted in one eye, the IMT is [...]
To: HEALTH, MEDICAL, AND NATIONAL EDITORSContact: Dick Thompson of U.S. Food and Drug Administration, +1-301-796-7566, dick.thompson@fda.hhs.govParticipants will explore how federal agencies can encourage medicaldevice developmentSILVER SPRING, Md., June 21 /PRNewswire-USNewswire/ Each day,medical devices from renal dialysis machines to implantabledefibrillators help prevent, diagnose, treat, and monitor serious andlife-threatening diseases. After taking years to develop, [...]
FDA NEWS RELEASEFDA to Hold Daylong Meeting on Medical Device InnovationParticipants will explore how federal agencies can encourage medical device developmentEach day, medical devices from renal dialysis machines to implantable defibrillators, help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before [...]
