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Second Sight Medical wins U.K. reimbursement nod for Argus II ‘bionic eye’
Second Sight Medical (NSDQ:EYES) said today that the U.K.’s National Health Service granted reimbursement for the company’s Argus II retinal prosthesis system for blind patients with retinitis...
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Sunovion, Novartis ink licensing deal for inhaled COPD drugs
Novartis (NYSE:NVS) said today that it out-licensed its U.S. commercial rights for 3 inhaled chronic obstructive pulmonary disease drugs to Sunovion Pharmaceuticals. Novartis will commercialize the...
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AirXpanders wins de novo FDA clearance for AeroForm breast tissue expander
AirXpanders (ASX:AXP) said yesterday it won FDA de novo clearance for its AeroForm tissue expander system designed for breast reconstruction procedures, and announced it is preparing to launch the...
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Report: US regulators poised to clear Abbott’s $25B St. Jude buy
Regulators in the U.S. are positioned to approve Abbott‘s (NYSE:ABT) $25 billion acquisition of St. Jude Medical (NYSE:STJ), according to 2 Reuters sources. The approval from the U.S. Federal Trade...
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Bipartisan report from senators calls for drug pricing reform
The U.S. Senate Special Committee on Aging released a bipartisan report yesterday suggesting ways to respond to spikes in drug pricing. The report comes after a months-long investigation spearheaded...
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Integra LifeSciences shareholders approve 2-for-1 reverse stock split
Integra LifeSciences (NSDQ:IART) said today that its shareholders have approved a 2-for-1 stock split, alongside an increase from 60 million to 240 million shares of stock. Shares are expected to be...
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MassDevice.com +5 | The top 5 medtech stories for December 22, 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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Teva coughs up $519m to settle overseas bribery charges
Teva Pharmaceuticals (NYSE:TEVA) will pay $519 million to settle allegations that the company bribed overseas officials in Mexico, Russia and Ukraine to promote its products, according to the U.S....
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Researchers develop flexible patch with stainless steel microneedles
Researchers from the KTH Royal Institute of Technology in Stockholm have developed a patch that combines stainless steel microneedles and a soft polymer base. The team’s work was published this month...
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European Commission: Entry into force of MDR, IVDR set for late May 2017
By Stewart Eisenhart, Emergo Group During the Eudamed Steering Committee meeting of December 14, 2016 the current state of play regarding the introduction of the new Medical Device Regulations (MDR)...
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iCad deals VersaVue software, DynaCAD to Philips InVivo unit for $3.2m
iCad (NSDQ:ICAD) said yesterday that it agreed to deal its VersaVue software and DynaCAD breast and prostate imaging devices to Royal Philips‘ (NYSE:PHG) InVivo unit for $3.2 million. Nashua,...
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AtriCure warns on tip detachment risk with Cobra Fusion cardiac ablation device
AtriCure (NSDQ:ATRC) in September warned doctors of the risk that the tip of its Cobra Fusion cardiac ablation catheter could dislodge and separate from the device. The Cobra Fusion device is designed...
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FDA approves Alcon’s AcrySof IQ ReStor intraocular lens
Novartis‘ (NYSE:NVS) eye care business, Alcon, said today that it won FDA approval for its AcrySof IQ ReStor multifocal toric intraocular lens. The lens treats presbyopia and pre-existing corneal...
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EnteroMedics readies 1-for-70 reverse split
EnteroMedics (NSDQ:ETRM) said today that its board declared a 1-for-70 reverse stock split effective Dec. 28, as part of the company’s plan to regain compliance with the NASDAQ exchange’s $1.00 minimum...
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Mesoblast gains on A$29m investment deal with Mallinckrodt
Shares in stem cell company Mesoblast Ltd (ASX:MSB) rose 7% to A$1.51 yesterday after it said that it entered into an equity purchase agreement with US drugmaker Mallinckrodt Pharmaceuticals...
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Presbia announces 2-year Microlens data from PMA trial
Presbia (NSDQ:LENS) touted interim data today from its U.S. pivotal clinical trial, which it hopes will eventually support pre-market approval from the FDA for its Flexivue Microlens. The company is 2...
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FDA expands clearance for Avinger’s Lightbox L250 vascular imaging console
Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after...
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FDA finalizes rule for post-market combination products safety reporting
By Stewart Eisenhart, Emergo Group For the first time, a final rule issued by the US Food and Drug Administration establishes post-market safety reporting requirements specifically for combination...
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Cardinal Health pays $44 to settle DoJ case
Cardinal Health (NYSE:CAH) said today it reached a settlement with the US Department of Justice, paying $44 million to clear up civil penalties related to a 2012 case with the US Drug Enforcement...
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Stryker’s Concentric Medical wins Class II FDA label for Trevo clot retrieval...
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II. Concentric Medical submitted a request for...
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