Health Care Equipment and Supplies


  • Dec 11- An advisory panel of medical experts voted on Wednesday to recommend that U.S. health regulators approve an experimental stroke-prevention device made by Boston Scientific Corp. The FDA typically follows the recommendations of its expert advisory panels, but is not obligated to do so.

  • WASHINGTON, Dec 11- As online enrollment accelerates for medical insurance under President Barack Obama's health law, the government is relying on manual back-up systems to correct computer errors that could leave some enrollees uninsured, the top U.S. health official said on Wednesday.

  • The FDA released documents about the device, called Watchman, ahead of a meeting on Wednesday of outside medical experts who will consider its risks and benefits and then recommend whether the FDA should approve the product for use in patients.

  • Dec 9- Boston Scientific Corp's anti-stroke device did not meet one measure of success in a clinical study of the implant, but other data must be considered when determining overall safety and effectiveness, staff members of the U.S. Food and Drug Administration stressed on Monday.

  • U.S. FDA warns of flaw in some Philips defibrillators Wednesday, 4 Dec 2013 | 2:55 PM ET

    The FDA the following month declared a Class II recall on the devices, citing a "remote" chance of severe adverse consequences or death due to the product flaw. FDA spokeswoman Jennifer Rodriguez said the agency issued its safety advisory on Tuesday because Philips has been unable to reach a significant number of its customers, to point out the potential risk.

  • *Tech adviser cites dramatic improvement since Oct. 1. Dec 1- Two months after the disastrous launch of a website that is a key component of President Barack Obama's healthcare law, administration officials said on Sunday they had met their goal of getting the HealthCare.gov site running smoothly but warned that it needs more fixes.

  • HealthCare.gov 'deploying well,' says White House Sunday, 1 Dec 2013 | 9:48 AM ET
    A healthcare reform specialist helps people select insurance plans at the free Affordable Care Act (ACA) Enrollment Fair at Pasadena City College in Pasadena, California.

    "The bottom line, healthare.gov is night and day from where it was on Oct 1," said Jeff Zients on Sunday, who is in charge of fixing the web site.

  • Nov 30- The rollout of President Barack Obama's healthcare law entered a critical phase on Saturday, the deadline for substantially fixing the program's troubled enrollment website, as the administration scrambled to address the most obvious glitches.

  • The Centers for Medicare and Medicaid Services said it is replacing data center services from Verizon Communications Inc's Terremark subsidiary, with services from Hewlett-Packard Co..

  • WASHINGTON, Nov 25- The Obama administration on Monday announced a plan to help HealthCare.gov visitors cope with online glitches if traffic surges after the troubled website is working smoothly for most people this weekend as promised.

  • 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."

  • Obamacare tech guru says website capacity to double Friday, 22 Nov 2013 | 3:55 PM ET

    WASHINGTON, Nov 22- HealthCare.gov, the ailing website handling health insurance sales under President Barack Obama's healthcare law, will soon be able to handle 50,000 simultaneous users, the top official charged with making it work said Friday.

  • WASHINGTON, Nov 21- In the last days before the botched Oct. 1 launch of President Barack Obama's healthcare website, the team in charge was seeing alarming results from performance tests, according to internal emails released by Republican lawmakers investigating the rollout.

  • 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.

  • Icahn reports large stake in medical device maker Thursday, 21 Nov 2013 | 10:25 AM ET
    Carl Icahn, billionaire investor and chairman of Icahn Enterprises Holdings LP

    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.

  • WASHINGTON, Nov 19- President Barack Obama, who has portrayed himself as surprised by technical problems with the government's new health care website, was briefed last spring on a detailed consultant's report that warned of system failure, White House spokesman Jay Carney said on Tuesday.

  • President Barack Obama' s healthcare overhaul has security flaws that put user data at "critical risk" despite recent government assurances it is safe to use, a respected security expert said on Tuesday.

  • 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.

  • SAN FRANCISCO, Nov 19- The rapid spread of utility meters, medical equipment and even cars connected to the Internet is drawing scrutiny from regulators and big business suppliers worried about privacy and security issues.

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