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MassDevice.com +3 | The top 3 medtech stories for November 25, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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FDA warns cosmetic device maker over lack of approval, demands halt to sales
The FDA this week released a warning letter it sent to cosmetic device maker A-1 Engineering over a lack of FDA clearance to market its devices, requesting the company halt sales of the devices. The...
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Diagnosing pediatric vestibular issues with an iPhone in a bucket
Dizziness is fairly common in children, but it can be very hard to diagnose the cause. Any number of conditions can produce dizziness, and children are a special challenge since they often can’t...
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St. Jude Medical’s Proclaim Elite debuts in Europe
St. Jude Medical (NYSE:STJ) said today that it’s launching its Proclaim Elite spinal cord stimulation device in the European Union after winning CE Mark approval there, including an indication for...
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UPDATE: FDA deems Boston Scientific’s atherectomy component recall Class I
The FDA last week slapped Class I status on Boston Scientific‘s (NYSE:BSX) recall of nearly 1,000 components used with its Rotablator atherectomy device. Boston Scientific warned doctors of the...
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UPDATE: Siemens Healthcare wins FDA nods for robotic X-ray scanner, Somatom...
UPDATED Nov. 30, 2015, with details on FDA clearance for Somatom low-dose CT. Siemens Healthcare (NYSE:SI) said it won 510(k) clearance from the FDA for its Multitom Rax robotic advanced X-ray...
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Jury hits Wright Medical with $11m verdict in Conserve hip implant bellwether
A federal jury in Georgia last week handed an $11 million loss to Wright Medical (NSDQ:WMGI) in the 1st bellwether trial in the multidistrict litigation filed over its Conserve metal-on-metal hip...
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Diabetes: Medtronic launches ‘Pattern Snapshot’ for iPro2 CGM
Medtronic (NYSE:MDT) said today that it launched a new “Pattern Snapshot” report for its iPro2 professional continuous glucose monitor that’s designed to give healthcare providers a 1-page overview of...
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Titan Medical inks instruments deal with Cadence Device
Titan Medical (CVE:TMD) said today that it inked a deal with Cadence Device for instruments for its Sport robot-assisted surgery platform. The deal calls for Cadence to develop, manufacture and manage...
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Report: IPOs headed for 6-year low
The market for initial public offerings is headed for a 6-year low not seen since the economy imploded in 2009, according to a report from Renaissance Capital. There have been 168 IPOs so far this...
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Supreme Court denies Covidien in $177m surgical shears spat with J&J’s Ethicon
The long-running patent infringement war between Medtronic’s (NYSE:MDT) Covidien subsidiary and Johnson & Johnson‘s (NYSE:JNJ) Ethicon Endo-Surgery unit over surgical shears appears to be over,...
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Biolitec loses Supreme Court bid to overturn $75m contempt ruling
German medical laser maker Biolitec (ETR:BIB) today lost its bid to have the U.S. Supreme Court review an appeals court decision upholding a $75 million contempt penalty in its longtime legal dispute...
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NinePoint Medical raises $30.7m for NvisionVLE imaging system
NinePoint Medical reported a funding round worth $30.7 million as it seeks to expand the commercial footprint for its NvisionVLE imaging system. The equity round, which began Nov. 12, involved 3...
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Danaher lures ex-Medtronic legal eagle Ellis for GC spot | Personnel Moves
Danaher (NYSE:DHR) said it lured Brian Ellis from Medtronic (NYSE:MDT) to be its new general counsel, replacing Jonathan Graham, who jumpoed ship for Amgen (NSDQ:AMGN) last May. Ellis was general...
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MassDevice.com +3 | The top 3 medtech stories for November 30, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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FDA: Class II recall for Medtronic’s InSync III pacemakers
A battery longevity issue prompted Medtronic this month warn doctors about some 96,787 of its InSync III pacemakers, an action the FDA labeled a Class II recall, although Medtronic said only about...
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Nevro beats Boston Scientific’s patent challenges
Nevro Corp. (NYSE:NVRO) yesterday beat a pair of challenges to 1 of its patents by Boston Scientific (NYSE:BSX), after the U.S. Patent & Trademark office declined to institute inter partes reviews....
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FDA: PMA approvals hit record high in fiscal 2015
The FDA this month said it approved a record 98% of the pre-market approval applications submitted for medical devices during fiscal 2015, its highest rate for the last 15 years. The federal safety...
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QT Vascular wins stay in $20m loss to AngioScore
QT Vascular and a pair of related companies last week won a stay in their $20 million loss to AngioScore so their appeal can proceed. In July, a federal judge ruled that founder Eitan Konstantino...
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PAD: Boston Scientific wins FDA, CE Mark nods for thrombectomy catheter
Boston Scientific (NYSE:BSX) said yesterday it won both FDA premarket approval and CE Mark approval in the European Union for its AngioJet ZeltanteDVT thrombectomy catheter designed to treat deep vein...
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