Category: C.R. BardSyndicate content

Bard: We're on track for early 2015 Lutonix approval

July 25, 2014 by Brad Perriello

Executives at C.R. Bard say the company is on track for an early 2015 approval for its Lutonix drug-eluting balloon for treating peripheral artery disease.

Bard: We're on track for early 2015 Lutonix approval

C.R. Bard (NYSE:BCR) is on track for an early 2015 U.S. approval of its Lutonix drug-eluting balloon, company executives said yesterday after reporting earnings growth that topped expectations.

Covidien logs $180M charge over pelvic mesh lawsuits

July 11, 2014 by Brad Perriello

Covidien says its exposure to a raft of product liability lawsuits filed over pelvic mesh products increased by some $131 million during its fiscal 3rd quarter.

Covidien logs $180M charge over pelvic mesh lawsuits

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FDA wants another advisory panel hearing for BSX Watchman anti-stroke device | Regulatory news for the week of June 23, 2014

June 24, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device; FDA talks Twitter and other online etiquette for medtech makers; Malaysian medical device market regulators clarify, expand policies; FDA issues draft guidances for industry on social media and internet communications about medical products: Designed with patients in mind; Scotland curbs use of transvaginal mesh amid global outcry.

FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device

June 17, 2014 by Brad Perriello

Scotland curbs use of transvaginal mesh amid global outcry

June 19, 2014 by Arezu Sarvestani

Scotland's regional health boards agree to suspend use of transvaginal mesh implants pending an investigation into complaints that the devices scar women for life.

Scottish regulators curb use of women's surgical mesh amid growing controversy

Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.

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FDA opens up about chat with Apple on company's healthcare prospects | Regulatory news for the week of June 16, 2014

June 17, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Digital health: Inside Apple's meeting with the FDA; FDA details plan to improve medical device arm; FDA panel OKs Bard's Lutonix balloon; Cohera Medical wins FDA panel date for TissuGlu surgical adhesive; FDA approves Medtronic's CoreValve for high-risk patients.

Digital health: Inside Apple's meeting with the FDA

June 10, 2014 by Arezu Sarvestani

Digital health: Inside Apple's meeting with the FDA

UPDATE: FDA panel OKs Bard's Lutonix balloon

June 13, 2014 by Ingrid Mezo

An FDA advisory panel recommends approval for C.R. Bard's Lutonix drug-eluting balloon for treating peripheral artery disease.

FDA panel OKs Bard's Lutonix balloon

UPDATED June 13, 2014, with comments from panel members.

An FDA advisory panel yesterday recommended approval for the Lutonix drug-eluting balloon made by C.R. Bard (NYSE:BCR).

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Bard announces $500M buyback

June 12, 2014 by Brad Perriello

C.R. Bard authorizes another share repurchasing program worth $500 million.

Bard announces $500M buyback

C.R. Bard (NYSE:BCR) said it plans to buy back as much as $500 million worth of its own stock, having spent all but $30 million of a prior share repurchasing plan also worth half a billion.

Companies often buy back their stock when they believe the market is undervaluing share prices, in an effort to raise the price.

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