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Mindray shareholders OK managers go-private buyout
Shareholders in Mindray Medical (NYSE:MR) voted today to approve the $3.3 billion proposal that would see the Chinese medical device company’s managers take it private. Mindray said the $28-per-share...
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Insulet’s Q4 sales surprise, but earnings miss badly
Insulet (NSDQ:PODD) yesterday surprised analysts on Wall Street with its 4th-quarter sales results, but missed the consensus earnings forecast by a wide margin. Fourth-quarter losses for the Billerica,...
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RIP medical device pioneer Alfred Mann | Personnel Moves
Alfred Mann, a medical device entrepreneur who helped develop several groundbreaking technologies, died yesterday at age 90, shortly after stepping down from a pair of companies he founded. Mann...
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FDA: Average PMA time to decision hits record low
The FDA released a report today detailing its stats for pre-market approvals and 510(k) applications for 2015 and the 1st 3 months of 2016, hitting a high-water mark for its time-to-decision for PMAs....
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Integra LifeSciences ekes out Street-beating Q4 numbers
Integra LifeSciences (NSDQ:IART) eked out some Wall Street-beating numbers for the 4th quarter and raised its outlook for 2016, prompting investors to send its share price up today. Plainsboro,...
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MassDevice.com +3 | The top 3 medtech stories for February 26, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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Versago raises $1.7m for ‘reverse needle’ access port
Versago Vascular Access said today it received $1.7 million in seed funding from Primo Medical Group’s network of investors to support its “reverse needle” subcutaneous access port. West Bridgewater,...
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FDA backs Endo’s Topas mesh to treat fecal incontinence
The FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee this week voted unanimously to back approval of Endo Health Solutions (NSDQ:ENDP) subsidiary Astora...
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GI Dynamics, in the red, says it has enough gas for 2016
GI Dynamics (ASX:GID) reported it has enough assets to continue through 2016 after reporting a rough fiscal year 2015, seeing sales shrink over 50% while net losses and losses per share trimmed down....
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APN Health wins 510(k) for 3D cardiac mapping system
Electrophysiology tool developer APN Health said today it won FDA 510(k) clearance for its Navik 3D advanced cardiac mapping system. The system from Pleasanton, Calif.-based APN Health is designed to...
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Vivify Health raises $17m for remote monitoring
Remote patient monitoring tech company Vivify Health said Wednesday it raised $17 million in a new round of financing to support its remote health monitoring tech. The round was led by healthcare...
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They sold their company to Boston Scientific and then reacquired the...
NuCryo Vascular GM Kevin Beedon Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of...
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In brief: Latest version of ISO 13485 published
By Stewart Eisenhart, Emergo Group The International Standards Organization has officially published the highly anticipated update to its ISO 13485 quality management system standard. ISO 13485:2016...
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Vascular Solutions, CEO Root beat criminal charges in off-label promotion case
A federal jury last week acquitted Vascular Solutions (NSDQ:VASC) and CEO Howard Root of charges that they ran an off-label promotion scheme for its now-discontinued Vari-Lase varicose vein treatment....
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UPDATE: FDA mandates new study, ‘black box’ label for Bayer’s Essure
Updated with comment from Bayer The FDA today said it would put a pair of measures in place for the controversial Essure permanent contraception device made by Bayer (ETR:BAYN), mandating a new...
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Report: Toshiba to sell entire medical equipment biz
Toshiba (TYO:6502) reportedly plans to sell its entire medical equipment unit, Toshiba Medical Systems, rather than just a controlling stake, setting the stage for an aggressive bidding war that could...
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Dentsply, Sirona Dental close $5.6B merger
Dentsply International (NSDQ:XRAY) and Sirona Dental Systems (NSDQ:SIRO) said today that they closed their $5.6 billion merger, after winning conditional approval last week from anti-trust regulators...
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TearLab to layoff 54 employees in restructuring
TearLab Corp. (NSDQ:TEAR) said today it is undertaking a strategic restructuring that will result in the loss of 54 employees as the company looks to tighten the bolts in pursuit of positive cash flow....
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Intuitive Surgical touts less complications in robot-assisted hysterectomy study
Intuitive Surgical (NSDQ:ISRG) today said that results from a study evaluating robotic-assisted hysterectomies were published in the International Journal of Gynecology and Obstetrics, indicating fewer...
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FDA approves InVivo neuro-spinal scaffold trial amendment
InVivo Therapeutics (NSDQ:NVIV) said today the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic...
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