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News Breaks
February 6, 2014
05:49 EDTMDTMedtronic introduces new generation Enlite glucose sensor
Medtronic announced the European launch of new generation Enlite, the latest iteration of the company's Enlite glucose sensor. New generation Enlite is designed to provide a more consistent and comfortable experience for people using continuous glucose monitoring, or CGM. Insulin pumps with built-in CGM provide more precise insulin delivery and lifestyle flexibility for people with diabetes. In addition to delivering small amounts of insulin around-the-clock, these integrated systems provide real-time glucose values and customizable alerts that give warning before glucose levels go too high or too low, prompting the person with diabetes to take preventative action.
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April 27, 2015
15:35 EDTMDTMedtronic announces consent decree with FDA for Synchromed system
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15:31 EDTMDTFDA enters consent decree with Medtronic
The FDA announced the filing of a consent decree against Medtronic and two of the company’s officers—S. Omar Ishrak and Thomas 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. The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment. The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
11:02 EDTMDTMedtronic begins clinical study of Endurant Evo AAA strent graft system
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April 21, 2015
11:02 EDTMDTMedtronic begins enrollment in feasibility study of Valiant Mona LSA system
Medtronic announced the start of a new feasibility study to evaluate the safety and effectiveness of the Valiant Mona LSA branch thoracic stent graft system, an investigational medical device designed to enable a completely endovascular solution for aortic aneurysms encroaching on the left subclavian artery. Cleveland Clinic cardiothoracic surgeon Dr. Eric Roselli successfully completed the first implant in the study on Thursday. He serves as the study's national primary investigator and receives consulting fees and honoraria for teaching from Medtronic. The study aims to enroll 24 subjects at up to seven sites in the United States. The purpose of the study is to characterize the safety and effectiveness of the investigational device acutely and at 30 days.
April 17, 2015
07:10 EDTMDTMedtronic's Solitaire improved neurological outcomes in stroke patients in trial
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April 14, 2015
11:04 EDTMDTMedtronic to develop stent graft system under patent agreement with Sanford
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09:16 EDTMDTMedtronic announces CE Mark for Micra TPS
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