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Galt Medical to Shut Down Texas Manufacturing Facility, Announces 139 Layoffs
Galt Medical Corporation (Garland, Texas) will lay off 139 employees as it shuts down a manufacturing facility in its hometown. Galt, a division of Theragenics, manufactures disposable surgical devices. The closure will take place over the next 24 months, beginning on September 30th.
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Sequester Hits to FDA Could Impact Med Device Approvals
With sequester cuts looming, FDA officials are struggling to find a way to maintain staff and support programs. In particular, the federal agency faces $83 million in cuts as it loses out on some user fees.
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Abbott Receives CE Mark for 48-mm Drug-Eluting Stent
Abbott has received CE Mark approval from the European Union for its Xience Xpedition 48 Everolimus Eluting coronary stent, which is designed for patients suffering from long blockages in blood vessels leading to the heart.
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German Police Seize Nearly 200 Stents from Boston Scientific
OrbusNeich Medical (Hong Kong) reports that 190 stent systems were seized from Boston Scientific’s offices in Germany as a result of a patent dispute between the two companies. The seizure followed a preliminary injunction that bans the sale of Boston Scientific’s stents in Germany. OrbusNeich claims that the injunction and the seizure were needed after Boston Scientific allegedly stated that the stents were not at its German offices.
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Medtronic Smashes Revenue Expectations
Medtronic reported that its fiscal fourth-quarter sales
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Supreme Court Agrees to Hear Medtronic Suit against Boston Sci
A patent dispute between Boston Scientific and Medtronic related to cardiac resynchronization therapy (CRT) devices is heading to the United States Supreme Court. The disputed CRT device patents are property of Mirowski Family Ventures. Boston Scientific received an exclusive license for these patents. While Medtronic did have a license for two of these patents, Mirowski Family Ventures claims that the company is developing new CRT devices that make use of its patents.
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FreeStyle InsuLinx Blood Glucose Meter by Abbott Receives Class I Recall Status
Abbott Laboratories has received Class I recall status for its FreeStyle InsuLinx blood glucose meters, which it stopped selling in the United States in April of this year.
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Medtronic Lands CE Mark for Export Advance Thrombus Removal System
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FDA Clears Covidien's Nellcor Pule Oximetry Portfolio
Covidien has received 510(k) clearance for its Nellcor pulse oximetry portfolio, making it the first FDA-cleared motion-tolerant pulse oximeter portfolio to comply with the ISO-802601-2-61pulse oximetry standard. Devices covered by the 510(k) include the Nellcor Bedside SpO2 Patient Monitoring System, the Nellcor Bedside Respiratory Patient Monitoring System and the Nellcor N-600x Pulse Oximetry Monitoring System.
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In Breast Implant Trial, PIP Lawyers Ask for Light Sentencing
Poly Implant Prothèse (PIP; La Seyne-sur-Mer, France) has been accused of selling hundreds of thousands of defective breast implants around the world. Now, the company’s founder Jean-Claude Mas along with four of his employees are facing four years of prison time for aggravated fraud.
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