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Syncardia files for Chapter 11 bankruptcy
Artificial heart maker SynCardia Systems filed for Chapter 11 bankruptcy last week after pulling an initial public offering last October. Syncardia makes an artificial heart system designed to...
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J&J’s DePuy can’t delay 3rd bellwether in Pinnacle hip MDL
A Johnson & Johnson (NYSE:JNJ) subsidiary can’t delay an upcoming bellwether trial in the multi-district litigation over its Pinnacle metal-on-metal hip implant, a federal judge in Texas ruled...
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MDR Analysis: Does your medical device fall under the scope of new European...
By Stewart Eisenhart and Ronald Boumans, Emergo Group The draft MDR text (see page 32 for the definition) as well as its accompanying Annex XV (page 352) lay out clear indications as to which types of...
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FDA warns Zimmer Biomet over quality system issues at Montreal plant
The FDA warned Zimmer Biomet (NYSE:ZBH) in May about a series of quality system violations the federal safety watchdog flagged during January inspections of a plant in Montreal. The plant makes the...
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Merit Medical pays $98m for DFine’s spine devices
Merit Medical (NSDQ:MMSI) said today that it paid $97.5 million in cash to acquire DFine and created a new division to incorporate DFine’s spine devices. San Jose, Calif.-based DFine makes the...
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Lombard expands EU launch of Altura AAA endograft system
Lombard Medical Technologies (NSDQ:EVAR) said today it expanded the European launch of its Altura endovascular stent graft to the Netherlands and Spain, touting 4 completed procedures with the device...
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NeoCoil recalls Flex Speeder MRI device on burn risk
Magnetic resonance imaging radiofrequency coil developer NeoCoil said it is recalling its 3 tesla 16 channel Flex Speeder large coil due to an increased burn risk. The company said that the recall was...
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Top execs retire as LivaNova retools, adds COO role
LivaNova (NSDQ:LIVN) said today that it’s retooling its organizational structure, adding a chief operating officer role and announcing the retirement of a pair of top executives. London-based LivaNova,...
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Event Cardio’s NowCardio remote cardiac monitor wins Health Canada OK
Heart monitoring system developer Event Cardio said today it won Health Canada approval for its NowCardio heart monitoring system, and will begin distribution in Canada this month. The NowCardio device...
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Prism Medical & Design wins FDA nod for ProteXsure anti-needle stick device
Prism Medical & Design said today it won FDA 510(k) clearance for its ProteXsure Safety Capsule System designed to prevent accidental needle sticks. The ProteXsure system contains 100 protective...
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MassDevice.com +5 | The top 5 medtech stories for July 6, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Judge slashes $500m jury verdict to $151m in J&J’s Pinnacle hip loss
A federal judge yesterday slashed a $500 million verdict against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics in the multi-district litigation over its Pinnacle metal-on-metal hip...
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Si-Bone’s new CCO is ex-Baxano CEO Recupero | Personnel Moves July 6, 2016
Si-Bone’s new CCO is ex-Baxano CEO Recupero Si-Bone said yesterday it tapped ex-Baxano (NSDQ:BAXS) CEO Tony Recupero as its new chief commercial officer. Prior to moving to Si-Bone, Recupero served as...
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Smith & Nephew touts Allevyn Life study of pressure ulcers
Smith & Nephew (NYSE:SNN) today released data from a new research publication analyzing ulcer prevention programs, which included use of the company’s Allevyn Life silicone foam dressing, touting a...
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Arthrex ponies up $5m royalty payment to Tiger X Medical
Arthrex this month paid $5.6 million in a royalty settlement and release agreement with Tiger X Medical, previously known as Cardo Medical, according to an SEC filing. The payment relates to a...
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India issues draft medical device regulations separate from drug law
By Stewart Eisenhart, Emergo Group Indian medical device market regulators have released new draft regulations following the government’s recent announcement that it would scrap the Drugs and Cosmetics...
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Senseonics takes out $30m term loan
Senseonics (NYSE:SENS) said yesterday that it took out a term loan worth $30 million from Oxford Finance and Silicon Valley Bank, augmenting the $45 million it raised in an initial public offering in...
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QT Vascular wins CE Mark for Chocolate Heart DCB
QT Vascular said today that it won CE Mark approval in the European Union for its Chocolate Heart drug-coated balloon for treating coronary artery disease. The Chocolate Heart device is a...
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Nelipak picks up thermoformer Tegrant Alloyd Brands from Sonoco
Nelipak said today that it acquired a thermoforming company in Puerto Rico, Tegrant Alloyd Brands, from Sonoco for an undisclosed amount. Get the rest of the story at our sister site, Medical Design...
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Private equity shop RoundTable Healthcare closes $140m Symmetry Surgical buy
RoundTable Healthcare Partners said this week that it closed the $140.3 million buyout of Symmetry Surgical, the legacy business formed after Symmetry Medical sold its orthopedics OEM operation to...
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