Key Developments: Medtronic Inc (MDT.N)

MDT.N on New York Stock Exchange

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17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

FDA Classifies Medtronic Inc's Worldwide Voluntary Field Action On Guidewires As Class I Recall
Friday, 15 Nov 2013 07:00pm EST 

Medtronic Inc announced that the U.S. Food and Drug Administration (FDA) has classified the Company's recently initiated voluntary field action related to certain guidewires as a Class I recall. Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the Company as soon as possible for credit and replacement. Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate. The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.  Full Article

Top U.S. Court Hears Arguments In Pacemaker Patent Fight Between Giant Medtronic Inc And Mirowski Family Ventures LLC-Reuters
Tuesday, 5 Nov 2013 06:25pm EST 

Reuters reported that the U.S. Supreme Court on November 05, 2013 heard arguments in a case of warring legal doctrines raised by a heart pacemaker patent fight between giant medical devices company Medtronic Inc and privately owned Mirowski Family Ventures LLC. The case stems from Medtronic's decision to request a declaratory judgment that some of its pacemakers do not infringe on technology patented by Mirowski and licensed to Boston Scientific and Guidant Corp, part of Boston Scientific and Abbott Laboratories. A court in Delaware said Medtronic was not infringing on the patents, but the U.S. Court of Appeals for the Federal Circuit threw out that ruling. Under legal doctrine, the company which files a lawsuit must prove its case. In this instance, that is Medtronic. And, under the same doctrine, a company which claims infringement must prove that infringement. In this case, that would be Mirowski. The justices focused most of their energies on Mirowski's lawyer in an almost one-hour hearing focused on which side bears the burden of proof, but legal experts declined to guess which way the court might rule. The case is Medtronic v Boston Scientific Corp, Guidant Corp, and Mirowski Family Ventures, U.S. Supreme Court, No. 12-1128.  Full Article

Apollo Hospitals and Medtronic Inc Announces Collaboration To Bring Portable Hemodialysis System To India
Wednesday, 9 Oct 2013 05:00am EDT 

Apollo Hospitals Enterprise Ltd., one of the healthcare providers in Asia, and Medtronic, Inc announced a collaboration to bring to market portable hemodialysis system in India to help improve access to care for End Stage Renal Disease (ESRD) patients who need Renal Replacement Therapy (RRT). This collaboration will leverage a Medtronic-developed technology platform, supported by clinical insight from Apollo. Both organizations envision an affordable and accessible health care delivery system that addresses the critical need for dialysis solutions in India. Medtronic intends to develop and manufacture key components of this system in India, with an investment of more than INR150 crore (USD25 million). For the first time, Medtronic is establishing an India R&D team that will focus on design, development and manufacturing of key components of the system in India. The commercial launch of the product is slated for 2016.  Full Article

FDA Panel Supports Broader Use Of Medtronic Inc's Heart Devices-Reuters
Tuesday, 8 Oct 2013 06:34pm EDT 

Reuters reported that a federal advisory panel recommended that Medtronic Inc be allowed to sell certain implantable electronic heart devices to a larger pool of patients, based on study results that showed the products reduced the risk of death and hospitalization. The panel of expert advisers to the U.S. Food and Drug Administration voted 4-3 on October 8, 2013, to recommend that Medtronic be approved to sell the products, called cardiac resynchronization therapy devices, to patients who suffer from an abnormal heart rhythm called atrioventricular block. The devices, also known as CRT-defibrillators and CRT-pacemakers, deliver electrical impulses to both lower chambers of the heart to restore its normal rhythm.  Full Article

MiMedx Group Inc Signs Distribution Agreement With Medtronic Inc
Tuesday, 1 Oct 2013 07:00am EDT 

MiMedx Group, Inc announced that it has entered into a distribution agreement with Medtronic, Inc. and SpinalGraftTechnologies, LLC, a wholly-owned subsidiary of Medtronic. Through the agreement, MiMedx will provide its PURION processed allograft products to Medtronic to be marketed by SGT for spinal applications. The MiMedx PURION processed allograft products distributed to Medtronic will be private-labeled. SGT will promote, market and sell the private-labeled allografts to its customers and end-users through-out the United States.  Full Article

Medtronic Inc Secures Approval Of First Artificial Pancreas Device System With Threshold Suspend Automation
Friday, 27 Sep 2013 08:30am EDT 

Medtronic, Inc announced the U.S. Food and Drug Administration (FDA) approval of the MiniMed 530G with Enlite, an artificial pancreas system with Threshold Suspend automation for people with diabetes. The MiniMed 530G system incorporates the new Enlite sensor, Medtronic's accurate continuous glucose sensor with a 31% improvement in overall accuracy from the previous generation. The MiniMed 530G system was approved for use by people with diabetes ages 16 and older. Medtronic will conduct a post-approval study including children ages two and older. The Enlite sensor can be worn for six days.  Full Article

Medtronic Inc Reaffirms FY 2014 Revenue Guidance-Conference Call
Tuesday, 10 Sep 2013 09:10am EDT 

Medtronic Inc announced that the Company will continue to be able to grow in guidance of 3% to 4% for the fiscal 2014. The Company reported revenue of $16.590 billion in fiscal 2013.  Full Article

Medtronic Inc Ratifies Appointment Of PricewaterhouseCoopers LLP As Independent Registered Public Accounting Firm-Form 8-K
Tuesday, 27 Aug 2013 02:18pm EDT 

Medtronic Inc reported in its Form 8-K that the shareholders ratified the appointment of PricewaterhouseCoopers LLP as the Company‚Äôs independent registered public accounting firm for the 2014 fiscal year.  Full Article

Medtronic Inc Announces Cash Dividend for Second Quarter of Fiscal Year 2014
Thursday, 22 Aug 2013 04:15pm EDT 

Medtronic Inc announced that it has approved a cash dividend of $0.28 per share of the Company's common stock. The dividend is payable on October 25, 2013, to shareholders of record at the close of business on October 4, 2013.  Full Article

Medtronic Inc Reaffirms FY 2014 Guidance-Conference Call
Tuesday, 20 Aug 2013 07:00am EDT 

Medtronic Inc announced that for fiscal 2014, it continue to believe that constant currency revenue growth of 3% to 4% remains reasonable and continue to expect non-GAAP diluted earnings per share (EPS) in the range of $3.80 to $3.85. The Company reported revenue of $16.590 billion in fiscal 2013. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $16.949 billion and EPS of $3.83 for fiscal 2014.  Full Article

Edwards shares up on injunction against Medtronic heart valve

- Shares of Edwards Lifesciences Corp jumped 13 percent on Monday after a U.S. court temporarily halted sales of competitor Medtronic Inc's heart valve implant that uses a less-invasive procedure to spare patients from open-heart surgery.

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