Author Archives: Andrea Gonzalez

EU finalizes more stringent CE mark rules with explosive ‘supernova’ of regulation

By John Brosky, Contributing Writer PARIS – The CE mark is dead, long live the new CE mark. Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council released the…

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Boston Scientific recalls first-gen Lotus valves due to locking mechanism issues

By Omar Ford, Staff Writer Boston Scientific Corp. said it was recalling its previous generation Lotus heart valve replacement devices following reports of problems with the products’ locking mechanisms. The Marlborough, Mass.-based company said the issue stems from excess tension…

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Medtronic strikes back with strong sales, rebounds from last quarter’s soft earnings

By Omar Ford, Staff Writer Medtronic plc revealed strong 3Q17 sales in its most recent earnings, distancing itself from a relatively bleak 2Q17. The Dublin-based company’s revenue grew about six percent during the three months ending on Jan. 27 compared…

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Live Webinar: Navigating the Complex Medical Technology Regulatory Landscape with Cortellis

The Global Regulatory landscape for Medical Devices has never been simple, but recent developments have opened new trap doors for the unwary device manufacturer. Join us for a live webinar on February 28 or March 2 featuring the editors of…

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Medrobotics picks up $20M to develop a host of additional indications for its Flex Robotic System

By Omar Ford, Staff Writer Medrobotics Corp. has closed on a $20 million preferred stock financing. Proceeds will be used to fund the Raynham, Mass.-based company’s expansion into new surgical applications for its Flex Robotic System. The company first gained…

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Freestyle Libre system gains ground over traditional glucose monitoring methods

By Omar Ford, Staff Writer Diabetes patients could receive more benefit from more noninvasive approaches to checking for glucose levels than the traditional finger-stick method. Abbott Laboratories Inc. released data from a study showing patients who scan more frequently with…

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Glaukos keeps PMA for Supra stent in sight, completes enrollment for IDE trial

By Omar Ford, Staff Writer Ophthalmic technology specialist Glaukos Corp. has completed patient enrollment in the pivotal phase of its investigational device exemption trial for the Istent Supra Suprachoroidal Micro-Bypass Stent. The San Clemente, Calif.-based company’s clinical trial includes 36…

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Integra Lifesciences in proposal to acquire J&J’s neurosurgery business for $1.05B

By Omar Ford, Staff Writer Integra Lifesciences Holding Corp. has made a bid to acquire Johnson & Johnson Corp.’s (J&J) Codman Neurosurgery business for $1.05 billion in cash. The neurosurgery business is part of New Brunswick, N.J.-based J&J’s Depuy Synthes…

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Acquisitions in aesthetics space continue with $1.65B proposed buy of Cynosure

By Omar Ford, Staff Writer Diagnostics specialist Hologic Inc. is slated to become the newest player in the aesthetics market with its proposed acquisition of Westford, Mass.-based Cynosure Inc. for $1.65 billion. Shares of Cynosure (NASDAQ:CYNO) jumped about 28 percent…

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Allergan continues to shape product portfolio with $2.48B acquisition of Zeltiq

By Omar Ford, Staff Writer Botox specialist Allergan plc is acquiring body-contouring product maker Zeltiq Aesthetics Inc. in a deal for about $2.48 billion. Shares of Pleasanton, Calif.-based Zeltiq Aesthetics Inc. (NASDAQ:ZLTQ) were at an all-time high, up 13.2 percent…

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