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Best of 2016: Top 10 regulatory stories
In a year of huge product debuts from major medical device players, a dark horse was the most-read regulatory story of 2016: Obalon Therapeutics and the weight-loss device it developed won that title...
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Best of 2016: The 10 most-read stories of the year
Each year, the editor’s of MassDevice write roughly 2,500 stories about the medical technology industry. These articles touch on the wins, the losses, the extraordinary and, sometimes, mundane...
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Lilly, Boehringer’s Basaglar long-acting insulin now available in the U.S.
Eli Lilly (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals said today that its insulin glargine injection, Basaglar, is available by prescription in the U.S. Basaglar is a long-acting insulin with...
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FDA denies Milestone Scientific’s Compu-Flo 510(k) application
Milestone Scientific‘s (OTC:MLSS) said today that the FDA denied the 510(k) application for its Compu-Flo intra-articular computer controlled injection system due to inadequate documentation showing...
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ClearLine wins CE Mark for intravenous line device
ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines. During IV infusion, ClearLine’s device detects air...
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MassDevice.com +5 | The top 5 medtech stories for December 15, 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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Researchers use nanoparticles to overcome treatment-resistant breast cancer
Researchers from the University of Cincinnati College of Medicine have developed RNA nanoparticles that show promise in overcoming treatment-resistant breast cancer. The team’s work was published in...
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EnteroMedics touts real-world vBloc data
EnteroMedics (NSDQ:ETRM) today released a real-world assessment of weight loss data from patients using its Maestro vBloc therapy device and associated programs, touting between 9% and 10% total weight...
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Sanovas launches SteriView subsidiary aiming to fight hospital-acquired...
Sanovas said yesterday it launched another subsidiary, SteriView, along with its SteriView instrument inspection and infection control system. The newly launched system is designed as a “front line...
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StimGuard launches OAB neurostim trial
StimGuard said today it enrolled the 1st patient in a clinical trial of its StimGuard miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder...
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New medical device registration requirements issued in South Africa
By Stewart Eisenhart, Emergo Group The South African Department of Health has issued new regulatory requirements covering both medical devices and in vitro diagnostic (IVD) devices, according to...
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SMC acquires UK auto-injector developer Oval Medical Technologies
SMC Ltd., said today that it acquired auto-injector developer Oval Medical Technologies for an undisclosed amount. Cambridge, UK-based Oval Medical Technologies develops auto-injectors for a 2-step...
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Fresenius expands prefilled syringe portfolio
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it added its heparin sodium injection to the company’s Simplist prefilled syringe portfolio. The prefilled syringe for subcutaneous...
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Mylan launches first generic EpiPen as state AGs sue generics makers for...
Mylan (NSDQ:MYL) launched its 1st generic EpiPen emergency allergy treatment 1 day after attorney generals from 20 states filed a civil complaint against Mylan, Teva Pharmaceuticals (NYSE:TEVA), and 4...
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Milestone Scientific prices $3m round
Milestone Scientific‘s (OTC:MLSS) today priced an upcoming offering, looking to raise approximately $3 million. The Livingston, N.J.-based company said it plans to offer 2 million shares of common...
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Actelion gains on Sanofi deal rumors
Actelion (VTX:ATLN) shares jumped more than 8% to 214 Swiss francs after reports that Sanofi (NYSE:SNY) and the Swiss biotech are nearing a takeover deal that would value Actelion at $29.6 billion....
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Evotec, Celgene ink drug development deal for stem cell treatments for...
Evotec (ETR:EVT) said today that it inked a 5-year drug discovery and development deal with Celgene (NSDQ:CELG) to identify stem cell therapies for a range of neurodegenerative diseases including...
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FDA issues final guidance on ’emerging signals’
[Image courtesy of OiMax on Flickr, per Creative Commons 2.0 license]FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry...
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QT Vascular wins full FDA IDE approval for Chocolate Touch DCB pivotal trial
QT Vascular said today it won full FDA investigational device exemption approval to initiate a trial of its Chocolate Touch drug-coated balloon designed to treat vascular disease. The Singapore-based...
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Flamel Technologies dose first patient in Phase III narcolepsy trial
Flamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and...
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