Device Recalls Surge in 2012 In the first quarter of 2012, FDA recalled 277 devices affecting 82 million units, recording a five-quarter high. |
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Boston Sci. gets EU Nod for New Stent The Innova self-expanding bare-metal stent is designed to treat peripheral vascular lesions in arteries above the knee; company plans to sell the stent immediately in Europe and other CE Mark countries. |
U.K. Regulator Blamed for Faulty Breast ImplantsA review by the U.K. government has concluded that while regulation couldn't have prevented everything, tighter scrutiny could have helped; and that the MHRA has "serious lessons" to learn from the PIP breast implant scandal. |
AdvaMed Asks IRS to "Be Reasonable" Lobby group submits 22-page of comments to IRS, as the countdown begins for implementing the Affordable Care Act's 2.3 percent medical device tax. |
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J&J Makes First Chinese Device Acquisition The healthcare giant picked up Guangzhou Bioseal Biotech for an undisclosed amount; acquisition is expected to broaden its business in China and expand a collection of products designed to control surgical bleeding. |
J&J CEO's Takeover Wish List In an interview Alex Gorsky talks about plans for merger and acquisitions to strengthen J&J's medical device units, especially in the cardiovascular space. |
Covidien on a Shopping Spree Following the acquisition of three Israeli med-tech companies in the past few weeks, there’s much speculation about Covidien’s M&A plans and next steps. |
Asahi Completes Phase 2 of Zoll buyoutAsahi Kasei now owns more than 93 percent of Zoll Medical, following the second phase of its $2.2 billion buyout of the automated external defibrillator maker. |
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FDA Attacks European Regulatory Process A strongly worded internal report trashes the European device approval system, which American device makers point to as a model for getting devices to patients faster. |
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Abbott, St. Jude Expand Cardiac Co-promotion Deal The arrangement will enable the companies to jointly promote each other's stents, defibrillators and other cardiac-related devices, imaging and diagnostic technologies, extending a co-promotional deal in place since 2008. |
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St. Jude Beats 1Q Estimates While first quarter earnings were better than expected, company posted weakening demand for implantable heart defibrillators. |
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Further Setback for St. Jude Over Riata A medical journal has rejected St. Jude’s request that it retract a published report which linked 20 deaths to failures of a heart device component made by the company. |
FDA Panel to Review Edwards' Sapien for High-Risk Cohort The Edwards Sapien transcatheter heart valve received FDA approval for the treatment of certain inoperable patients in November 2011. It is currently an investigational device for the treatment of high-risk patients in the U.S. and is awaiting approval. |