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Chinese regulators warn of software glitch in Philips’ Pinnacle3 radiation...
Chinese regulators warn about a malfunction in Philip's Pinnical3 software that can affect medication dosages in the radiation therapy devices.Technology giant Philips (NYSE:PHG) warned healthcare...
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EuroZone OKs Medtronic's CoreValve for valve-in-valve implants
Medtronic wins CE Mark approval in the European Union for its CoreValve heart valve, for use in valve-in-valve procedures to replace failing surgically implanted replacement valves.Medtronic (NYSE:MDT)...
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Boston Scientific legal update: Ups and downs in tussles with Iraq,...
Medical device titan Boston Scientific provides updates on some of its long-standing legal battles, including a mass-complaint from the Iraqi government, a dwindling whistleblower lawsuit over stent...
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Medical device tax: AdvaMed responds to another repeal critic
Medical device industry lobbying firm AdvaMed challenges an LA Times opinion piece that called medtech tax repeal efforts "repeal efforts "narrow-minded and dishonest."Critics of the medical device tax...
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How reliable are blood glucose meters? Post-market studies raise concerns
Researchers are beginning to raise alarms after finding that blood glucose meters on the U.S. market frequently fail to meet the same standards that won them FDA clearance.A handful of studies...
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MassDevice.com +3 | The top 3 med-tech stories for May 29, 2013
If you read nothing else today, make sure you're still in the know with MassDevice +3.Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of...
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Device makers object to FDA's proposed recall guidance | MassDevice.com On Call
Medical device titan Boston Scientific and industry lobbying group AdvaMed respond to the FDA's latest draft guidance on medtech recalls, warning that the new language may cause more confusion than it...
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FDA enforcement letter: Preview of U.S. mHealth regulations?
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the...
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Who's buying into Panasonic's healthcare business? Rumors abound
Word on The Street is that tech titan Toshiba and private equity firm Kohlberg Kravis Roberts & Co. are vying for a chance to nab shares of Panasonic's healthcare business.News Well, Venture...
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Mercator MedSystems raises $6.5M for Cricket, Bullfrog micro-infusion systems
California medical device maker Mercator MedSystems touts a new $6.5 million Series B financing round in support of commercial sales efforts for its Bullfrog and Cricket micro-infusion drug-delivery...
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Investors shrug off FDA warning letter for Edwards
Shares of Edwards Lifesciences tick up today despite news of an FDA warning letter for the implantable heart valve maker.Investors seemed unfazed by news of a warning letter from the FDA for Edwards...
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Boston Scientific's 5-part recipe for success
Boston Scientific lays out its 5 "strategic imperatives" for driving growth.Medical device giant Boston Scientific (NYSE:BSX) has been soaring in recent months, with BSX shares up more than 50% since...
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Nobel Biocare settles $450M class action for $1.3M
Nobel Biocare could pay $1.3 million to settle a class-action lawsuit over allegedly defective dental implants. Nobel Biocare Holding may be able to settle a class action lawsuit involving 1,000s of...
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Sensus Healthcare wins another indication for melanoma treatment
The FDA says Sensus Healthcare's non-surgical skin cancer treatment can be used to treat keloid scars.The FDA granted another indication for Sensus Healthcare's topical skin cancer device, for treating...
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AngioDynamics lets sales manager Panzer go | Personnel Moves
AngioDynamics lets U.S. sales general manager Alan Panzer go "without cause."keys: angiodynamics, cfo, alan panzer Albany, N.Y.-based AngioDynamics (NSDQ:ANGO) said Alan Panzer, its general manager of...
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Legal: Former ArthroCare exec wants court to reveal accused co-conspirators
A former ArthroCare executive accused of misleading investors tells a Texas judge that he can't properly prepare for a trial unless the court releases the names of his alleged co-conspirators.Former...
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Hansen gains on FDA nod for heart rhythm trial
The FDA allows Hansen Medical to scale down its atrial fibrillation trial, raising share prices more than 2% today.Hansen Medical (NSDQ:HNSN) won a tentative FDA nod to dramatically scale down a...
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Legal news: J&J's Biosense Webster can't keep ex-reps from selling for St. Jude
A federal judge shoots down Biosense Webster's bid to keep a trio of former sales reps from working for cardiac rhythm management rival St. Jude Medical.Legal News, News Well, Cardiac Rhythm...
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FDA warns CooperSurgical about Texas manufacturing plant
FDA inspectors cite manufacturing violations at CooperSurgical's Texas facility, where the company produces its Uterine Manipulator Handle, Koh-Efficient and Stays devices.The FDA issued a warning to...
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MassDevice.com +3 | The top 3 med-tech stories for May 30, 2013
If you read nothing else today, make sure you're still in the know with MassDevice +3.Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of...
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