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Health Care Equipment and Supplies Health Care Equipment

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  • Olympus did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks. Medical device manufacturers are required to report serious device problems to the FDA within 30 days of learning about them. The FDA inspected four company sites in Japan and the U.S. between March and April this year.

  • Aug 6- Medtronic Plc has recalled 6,912 units of loading system of a recently approved heart device after reports of the presence of particulates. All affected systems have been withdrawn from the market, Medtronic spokeswoman Wendy Dougherty told Reuters on Thursday, adding that no affected loading systems had been released commercially in the United...

  • These wearables can read your mind and mood Sunday, 2 Aug 2015 | 7:00 AM ET
    Man and woman using Muse Headbands

    These wearables can read your mind and mood. Companies like Interaxon, Thync and Scanadu are leveraging EEG sensors to help users control their thoughts.

  • BOSTON, July 31- The U.S. Food and Drug Administration on Friday advised hospitals not to use Hospira Inc's Symbiq infusion system, saying a security vulnerability could allow cyber attackers to take remote control of the system. Both the FDA and DHS said they know of no cases where such an attack has been launched, but the FDA said in its advisory that it strongly...

  • July 28- Edwards Lifesciences Corp on Tuesday raised its full-year profit forecast, citing strong demand for the medical device maker's replacement heart valves that are implanted in a minimally invasive procedure. The company said it now expects full-year earnings, excluding items, of $4.30 to $4.40 a share. Edwards reported quarterly net income of $112.7...

  • UPDATE 1-Bellerophon's heart device fails study Monday, 27 Jul 2015 | 7:31 AM ET

    July 27- Bellerophon Therapeutics Inc said its implantable heart device failed to prevent heart failure in patients in a large study, casting doubts over an approval for the device in Europe. The device, Bioabsorbable Cardiac Matrix, was licensed to Bellerophon by BioLineRx Ltd in 2009.. BioLineRx's U.S.-listed shares fell 18 percent to $1.76 in premarket...

  • Bellerophon's heart device fails study Monday, 27 Jul 2015 | 6:36 AM ET

    July 27- Bellerophon Therapeutics Inc said its implantable heart device failed to prevent heart failure in patients in a large study, casting doubts over an approval for the device in Europe. The device, Bioabsorbable Cardiac Matrix, was tested in 303 patients who had already suffered a heart attack. The device was licensed to Bellerophon by BioLineRx Ltd in...

  • July 23- Boston Scientific Corp cut its full-year profit forecast for the second time in the face of rising litigation costs linked to problems with its implantable device used to treat feminine stress urinary incontinence. A Delaware jury last month ordered Boston Scientific to pay $100 million to a woman injured by the mesh, the largest-ever verdict...

  • Boston Scientific profit soars Thursday, 23 Jul 2015 | 7:10 AM ET

    July 23- Medical device maker Boston Scientific Corp, dogged by litigation expenses last year, reported a jump in quarterly profit. Net income attributable to the company rose to $102 million, or 8 cents per share, in the second quarter ended June 30, from $4 million, or break even on a per share basis, a year earlier. Revenue fell 1.6 pct to $1.84 billion.

  • July 10- Edwards Lifesciences Corp said it would buy privately held heart device maker CardiAQ Valve Technologies Inc for up to $400 million to expand its portfolio of less-invasive mitral valve replacement devices. The deal comes nearly two months after Edwards stopped enrolling patients for a study of its less-invasive mitral heart valve device, Fortis.

  • Seprafilm, developed by Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they heal. The FDA and Genzyme, which was bought by Sanofi in 2011, were not immediately available for comment. FDA database of Manufacturer and User Facility Device Experience cites at least nine reports that link Seprafilm...

  • June 23- Medtronic Inc said it was recalling certain lots of its of its tracheostomy tubes, devices used to ease breathing, after receiving complaints, including reports of 12 serious injuries. The medical device maker said it began notifying hospitals and distributors on May 8 that affected lots of its Covidien Shiley tracheostomy tubes were formed with a...

  • Mount Sinai CEO sees doom in looming Obamacare case Saturday, 20 Jun 2015 | 9:00 AM ET
    Supporters of the Affordable Care Act gather in front of the U.S Supreme Court during a rally in Washington last March.

    Mount Sinai's CEO sees a "death spiral" could occur if the Supreme Court rules against the health insurance subsidies in Obamacare.

  • June 12- The U.S. Food and Drug Administration said it approved a brain implant from St. Jude Medical Inc that helps reduce symptoms of Parkinson's disease and essential tremor, a neurological disorder that causes rhythmic shaking. The device can be used when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance...

  • Bad news is good for these stocks Wednesday, 10 Jun 2015 | 7:07 PM ET

    Bad news has been a boon for Malaysia's rubber glove makers, with the ringgit's drop and South Korea's MERS outbreak likely to provide a twin boost.

  • Insulet gets FDA warning letter over some insulin pumps Wednesday, 10 Jun 2015 | 6:05 PM ET

    June 10- Insulet Corp said on Wednesday it received a warning letter from the U.S. Food and Drug Administration over some of the company's insulin pumps. The company said the letter, which it received on Monday, followed an inspection by the FDA of its facility in Billerica, Massachusetts in March. The letter relates to the release of certain lots of the company's...

  • June 2- Medical device maker Medtronic Plc reported better-than-expected adjusted quarterly profit on higher sales across its business lines in its first quarter, including revenue from the acquisition of surgical products provider Covidien Plc. Wall Street shrugged off the currency hit, with Medtronic's shares edging slightly higher to $76.72 in...

  • June 2- Medical device maker Medtronic Plc reported a better-than-expected adjusted quarterly profit, helped by higher sales of its heart devices. The results are the first to include revenue generated by Covidien, which Medtronic acquired in January for $49.9 billion. Medtronic said on Tuesday revenue from its minimally invasive therapies group, which it...

  • June 2- Medical device maker Medtronic Inc reported a better-than-expected adjusted quarterly net income, helped by sales of its heart devices. The company's adjusted net profit rose to $1.68 billion, or $1.16 per share. The quarterly results are the first to include revenue generated by Covidien Plc, which Medtronic acquired in January for $49.9 billion.

  • Biotech isn't only health-care bet beating market Monday, 1 Jun 2015 | 10:09 AM ET
    An employee works on a stent graft component in a sterile environment at the Medtronic assembly plant in Tijuana, Mexico.

    The health-care sector is hot, and investors don't have to bet on the riskiest biotech stocks to profit.