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ZipLine Medical wins Chinese clearance, launches Zip surgical skin closure...
ZipLine Medical said yesterday that it won Chinese FDA approval for its Zip surgical skin closure device and commercially launched the device in the region. The Campbell, Calif.-based company’s Zip is...
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InVivo enrolls 10th patient in Inspire neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today it added a new patient to the Inspire study of its neuro-spinal scaffold. The Cambridge, Mass.-based company’s neuro-spinal scaffold is designed to be...
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Milestone Scientific closes $3m round
Milestone Scientific‘s (OTC:MLSS) said today it closed a $3 million round, selling approximately 2 million shares at $1.50 per share. Each share sold includes warrants for the purchase of an additional...
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21st Century Cures Act: Making progress on shared goals for patients
By: Robert M. Califf, M.D. Today, President Obama signed into law the 21st Century Cures Act, which, I am pleased to report, builds on FDA’s ongoing efforts to advance medical product innovation and...
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Varian Medical Systems puts up $276m for PerkinElmer’s medical imaging biz
Varian Medical (NYSE:VAR) said today that it agreed to put up $267 million to acquire the medical imaging business of PerkinElmer Inc. (NYSE:PKI) for the planned spinout of its Varex imaging components...
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Another warning for CareFusion’s Alaris drug pump
The Medicines & Healthcare products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger...
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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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