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OptiNose touts Phase III data for exhaled breath drug delivery
OptiNose touted data from a pair of Phase III clinical trials proving the safety and efficacy of its exhaled breath drug delivery treatment for chronic rhinosinusitis patients with and without polyps....
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Acclarent wins FDA nod for Aera Eustachian tube balloon
Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said today that it won de novo clearance from the FDA for its Aera Eustachian tube balloon dilation system, designed to treat persistent Eustachian...
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HHS, FDA finalize reporting rules for ClinicalTrials.gov
The U.S. Department of Health and Human Services and the FDA today released a final rule on results-reporting requirements for ClinicalTrials.gov, expanding registration requirements and providing a...
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MassDevice.com +5 | The top 5 medtech stories for September 16, 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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Johnson & Johnson to buy Abbot optics biz for $4.3B
Johnson & Johnson (NYSE:JNJ) said today it inked a deal to pick up Abbott‘s (NYSE:ABT) Medical Optics business for $4.3 billion in cash. The deal includes Abbott’s subsidiary Abbot Medical Optics,...
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Agilent prices $300m notes offering
Agilent Technologies (NYSE:A) today released pricing for a $300 million public offering of senior notes, with proceeds slated to repay its revolving credit facility. The Santa Clara, Calif.-based...
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Med-El USA wins FDA nod for Synchrony EAS hearing implant
Med-El USA said today it won FDA premarket approval for its Synchrony electric acoustic stimulation hearing implant system. The Synchrony EAS uses both the Synchrony cochlear implant designed to...
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Skyline Medical shareholders approve reverse split
Skyline Medical said today that stockholders approved a set of proposals including a reverse stock split and doubling the number of authorized shares of common stock. The reverse stock split will be...
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Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday the Centers for Medicare and Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with the company’s...
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Staar Surgical inks 44-hospital distribution deal in India
Staar Surgical (NSDQ:STAA) said yesterday it inked a distribution agreement with India-based EyeQ Vision Private to distribute Staar Evo Visian ICL intraocular lenses as a treatment for refractive...
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Boston Scientific wins CE Mark for Lotus Edge heart valve
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Lotus Edge, the next generation of its transcatheter aortic valve replacement. Marlborough,...
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FDA adjusts 510(k) third party review program ahead of MDSAP
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: FDA draft guidance clarifies how Third Party Review process aligns with the Medical Device Single Audit Program (MDSAP). This guidance...
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Gore launches trial for Tag thoracic branch endoprosthesis
W.L. Gore & Assoc. said today that it enrolled the 1st patient in a pivotal study evaluating its Tag thoracic branch endoprosthesis as a treatment for lesions of the aortic branch and descending...
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Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve
Edwards Lifesciences (NYSE:EW) said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement. The expanded indication...
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Sancilio withdraws $86m IPO for lipid-based drug delivery
Sancilio Pharmaceuticals last week withdrew its plans for an initial public offering it hoped would bring in $86 million for its Advanced Lipid Technology drug delivery platform. The Florida-based...
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Sanofi sues Merck over injected insulin
Sanofi Aventis (NYSE:SNY) said today that it filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK) over 10 U.S. patents related to its injected insulin device. The...
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Medtronic touts CRT study showing heightened medication adherence
Patients implanted with cardiac resynchronization devices showed a greater rate of adherence to their medication regimens after their CRT devices were put it, according to a retrospective study...
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Alphatec shuffles the deck | Personnel Moves, Sept. 19, 2016
Alphatec shuffles the deck Alphatec (NSDQ:ATEC) said it returned chairman Leslie Cross to the corner office as interim CEO, effective Sept. 16, and made a few other changes in the executive suite....
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China’s Venus Medtech launches CE Mark trial for pulmonary valve replacement
Chinese heart valve maker Venus Medtech said today that it launched a clinical trial to support CE Mark approval in the European Union for its Venus P transcatheter pulmonary valve, designed to treat...
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Microchip mimics human cells for drug trials
A physics professor from the University of Texas in Dallas reportedly created a microchip that mimics human cells to study the effects of cancer-fighting drugs. Jason Slinker, who started working on...
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