Allergan rose$. 58 or. 6 percent, to $96.50. Baxter International Inc. fell$. 07 or. 1 percent, to $66.70. Boston Scientific Corp. rose$. 03 or. 3 percent, to $11.34.» Read More
In a warning letter dated Nov. 22 and released on Monday, the FDA said it considers the company's product a medical device that therefore requires regulatory clearance, "as FDA has explained to you on numerous occasions."
Allergan fell$. 36 or. 4 percent, to $98.21. Baxter International Inc. rose$. 04 or. 1 percent, to $67.82. Boston Scientific Corp. fell$. 02 or. 2 percent, to $12.03.
Nov 21- Activist investor Carl Icahn disclosed a 12.63 percent stake in medical device maker Hologic Inc, prompting the company to adopt a shareholder rights plan to protect itself from hostile takeovers. Shares of Hologic, which makes screening tests for cancer and other diseases, rose 3 percent in late morning trading.
Activist investor Carl Icahn reported a 12.63 stake in medical device maker Hologic, prompting the company to seek protection from a hostile takeover
Nov 21- Activist investor Carl Icahn reported a 12.63 percent stake in medical device maker Hologic Inc, prompting the company to adopt a shareholder rights plan to protect itself from hostile takeovers.
Nov 19- Medtronic Inc reported higher quarterly earnings on Tuesday as stronger sales of its implantable devices to treat abnormal heart rhythms offset weakness in its spinal products business.
Nov 18- Medical device maker CareFusion Corp said it will buy GE Healthcare's respiratory care and anesthesiology products business, Vital Signs, for $500 million.
Nov 12- Johnson& Johnson will pay more than $4 billion to settle thousands of lawsuits over its recalled defective hip implants, Bloomberg reported late on Tuesday, citing three people familiar with the deal. Johnson& Johnson declined to comment on the report.
WASHINGTON, Nov 5- The U.S. Supreme Court on Tuesday 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.
Medtronic is preparing to launch the product in the United States, pending regulatory approval. Medtronic said it expects to launch the product in the United States for use in extreme-risk patients before its fiscal year ends in April 2014, noting that the U.S. Food and Drug Administration determined it has sufficient information to evaluate the device.
Oct 28- Edwards Lifesciences Corp on Monday reported higher-than-expected quarterly earnings, but investors were disappointed with the pace of U.S. sales of its newest artificial heart valves, sending its shares down more than 4 percent.
Oct 28- Edwards Lifesciences Corp on Monday reported higher-than-expected quarterly earnings as it benefited from strong sales of artificial heart valves that are implanted without major invasive surgery. Third-quarter net income rose to $77 million, or 68 cents per share, from $69 million, or 58 cents per share, a year earlier.
Oct 25- The U.S. Food and Drug Administration has approved Abbott Laboratories' MitraClip medical device, used to stop heart valve leakage in patients deemed unable to endure valve repair through open heart surgery, the company said on Friday. "We think longer term in the U.S., could be a $500 million product," said RBC Capital Markets analyst Glenn Novarro.
Oct 25- Abbott Laboratories said on Friday that the U.S. Food and Drug Administration approved its MitraClip medical device, used to stop heart valve leakage. A slim majority of advisers to the FDA had recommended approval of the implantable heart device, as some had questioned whether it would be effective for its intended use.
WASHINGTON, Oct 24- Medical device maker Stryker Corp will pay $13.2 million to settle civil charges the company bribed doctors and government officials to win business in five different countries, U.S. regulators said Thursday.
WASHINGTON, Oct 24- Medical device maker Stryker Corp will pay $13.2 million to settle civil charges alleging the company bribed doctors and government officials to win business in five different countries, U.S. regulators said Thursday.
Oct 23- Medical device maker Varian Medical Systems Inc reported lower-than-expected fourth-quarter results as demand for its products fell due to uncertainties related to U.S. healthcare reforms and reimbursement cuts. The company's fourth-quarter net earnings fell 2.4 percent to $117.3 million or $1.08 per share.
Proposals to toughen up European Union legislation on medical devices followed a 2011 scandal involving France's now defunct Poly Implant Prothese, which for up to a decade made substandard breast implants that were used by hundreds of thousands of women worldwide.
*FDA asks for new trial for Iluvien. *PSivida, which sold Iluvien rights, plunges 39 pct. The FDA raised concerns about the eye implant's safety profile in its complete response letter rejecting marketing approval, the company said on Friday.
*FDA asks for new trial for Iluvien. The FDA raised concerns about the eye implant's safety profile in its complete response letter rejecting marketing approval, the company said on Friday. The FDA also referred to deficiencies at the facility where Iluvien is manufactured, Alimera said.