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December 5, 2012
08:04 EDTMDT, ABMD, THORThe FDA Circulatory Systems Devices Panel holds a meeting
The Panel discusses and makes recommendations regarding the 515(i) order issued by the FDA on April 9, 2009 , for the external counter-pulsating (ECP) devices and the Intra-aortic balloon and control systems, one of the remaining pre-Amendment Class III devices, in a meeting being held in Gaithersburg, Maryland on December 5 at 8 am. Webcast Link
News For MDT;THOR;ABMD From The Last 14 Days
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October 7, 2015
11:32 EDTMDTLeerink medical supplies/devices analyst holds analyst/industry conference call
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October 6, 2015
12:36 EDTMDTMedtronic previews clinical studies ahead of symposium
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October 5, 2015
15:15 EDTTHOR, MDTStudy finds potential stroke risk with prosthetic heart valves
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10:52 EDTTHORAnalysts downplay potential impact of St. Jude FDA warning letter
Shares of St. Jude Medical (STJ), a developer, manufacturer and distributor of cardiovascular medical devices, are slightly higher in morning trading after analysts said that the company's receipt of a U.S. Food and Drug Administration warning letter for its Atlanta facility "doesn't look that bad." WHAT'S NEW: On Friday afternoon, St. Jude Medical disclosed in a regulatory filing that it received a warning letter from the FDA, which related to "observed non-conformities" at its Atlanta facility, where it manufactures the CardioMEMS HF system. St. Jude said that the FDA had from June 8-26 inspected the company's Atlanta facility and that various devices of the company manufactured at its Atlanta plant were found to be "adulterated." The FDA also said certain of the company's manufacturing, packing, storage and installation practices "are not in conformity" to the current goods and manufacturing practice requirements. St. Jude said it would continue to manufacture and ship the product from the Atlanta facility and does not expect customer orders to be impacted. WHAT'S NOTABLE: In January 2013, the FDA sent St. Jude Medical a warning letter detailing concerns regarding processes at the company's Sylmar, California facility; the letter did not raise any safety concerns about St. Jude Medical products. The company later detailed efforts to correct problems found during the inspection at the plant, which makes heart defibrillator leads. ANALYST REACTION: Deutsche Bank analyst Kristen Stewart kept a Hold rating on the stock and said that the warning letter "doesn't seem that bad" because St. Jude does not expect any impact on its ability to fulfill or ship customer orders and does not expect a material financial impact relating to the matter. Stewart noted that the FDA "seems satisfied" with the remediation made and has not expressed concerns about the need for a product recall or stop shipment. Similarly, Piper Jaffray analyst Brooks West believes the warning letter will not have a commercial impact on the company, and that the cost of alleviating the FDA's observations "are limited." West has an Overweight rating and $84 price target on the stock. PRICE ACTION: St. Jude Medical is up 0.2% to $63.94 in morning trading. ANOTHER TO WATCH: Thoratec (THOR), which agreed in late July to be acquired by St. Jude Medical, is essentially flat at $63.45.
October 2, 2015
10:02 EDTABMDHigh option volume stocks
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September 30, 2015
18:07 EDTTHORS&P announces changes to the S&P 400, 500 indices
S&P 500 constituent Joy Global (JOY) will replace Thoratec (THOR) in the S&P MidCap 400, and Verisk Analytics (VRSK) will replace Joy Global in the S&P 500 after the close of trading on Wednesday, October 7. S&P 500 constituent St. Jude Medical (STJ) is acquiring Thoratec in a deal expected to be completed on or about that date, pending final approvals. Joy Global has a market capitalization more representative of the mid-cap market space.
17:19 EDTTHORJoy Global to replace Thoratec in S&P 400 as of 10/7 close
09:05 EDTMDTMedtronic announces FDA approval of expanded use of Verify Evaluation System
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September 28, 2015
16:55 EDTMDTMedtronic sees one-time $500M charge in 2Q16
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08:36 EDTMDTMedtronic acquires Lazarus Effect
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September 27, 2015
17:29 EDTTHORThoratec reports HeartMate 3 CE Mark trial met primary endpoint
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September 23, 2015
07:53 EDTMDTUBS medical supplies & devices analyst holds an analyst/industry conference call
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