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Emergo analysis: Fewer 510(k) submissions from US medical device firms in 2015
By Stewart Eisenhart, Emergo Group In 2015, fewer US-based medical device companies submitted 510(k) applications to the Food and Drug Administration than at any point in the last five years. Also last...
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Analyst doubts FDA’s estimate of fetal deaths linked to Bayer’s Essure
An analyst who examined the FDA’s adverse events website for cases involving the controversial Essure permanent contraception device made by Bayer (ETR:BAYN) said the federal safety watchdog likely...
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Fresenius to settle dialysate lawsuits for $250m
Fresenius Medical Care (NYSE:FMS) said yesterday that its North American subsidiary agreed in principle to a $250 settlement of the multi-district litigation brought over its GranuFlo and NaturaLyte...
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Medtronic touts Solitaire stent retriever meta-analysis
The Solitare stent retriever Medtronic (NYSE:MDT) acquired for $50 billion last year when it bought Covidien is safe and highly effective when combined with standard care using the thrombolysis drug...
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IBM to pony up $2.6B for Truven Health Analytics
International Business Machine (NYSE:IBM) said today that it agreed to acquire Truven Health Analytics for $2.6 billion, marking IBM’s 4th major health-related acquisition since launching Watson Health...
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The steady and successful climb of BaroNova
Hugh Narciso, CEO of BAROnova Welcome to the Medsider interview, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder, Medsider. We...
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Stryker consolidation leads to 200-job expansion in Texas
Stryker (NYSE:SYK) is reportedly expanding its Stryker Communications operation in Texas as it consolidates other businesses in South Carolina and the Lone Star State. Kalamazoo, Mich.-based Stryker is...
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Stealthy Vicarious Surgical raises $2.4m
Stealthy Vicarious Surgical said it raised nearly $2.4 million for the surgical virtual reality software it’s said to be developing. Cambridge, Mass.-based Vicarious reported the equity offering, which...
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U.S. securities regulator levels new charges in press release hacking case
(Reuters) — The SEC charged 9 new defendants in what it has called a more than $100 million international scheme to hack into newswires that distribute corporate press releases and to use stolen...
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Biotronik claims Orsiro stent beats Boston Scientific’s Xience in heart...
Biotronik today touted study results showing that its hybrid Orsiro drug-eluting stent may have the edge on the Xience Prime and Xience Xpedition stents made by Boston Scientific (NYSE:BSX) in patients...
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Report: AdvaMed to tap BIO COO Whitaker for CEO
AdvaMed, the national lobby for the medical device industry, is reportedly planning to tap the chief operating officer at BIO, Scott Whitaker, to be its new CEO. If the report put out today by Politico...
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Congress targets FDA’s pre-market reviews, clinical trials for medical devices
By Stewart Eisenhart, Emergo Group Legislation advancing through both houses of the U.S. Congress would require “least burdensome” training of FDA staff involved in pre-market reviews of medical...
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Johnson & Johnson loses another pelvic mesh suit
A federal jury in Georgia deliberated for 3 hours yesterday before delivering another loss to Johnson & Johnson (NYSE:JNJ) in a product liability lawsuit brought over pelvic mesh products. The jury...
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Essilor’s 2015 profit rises, sees higher revenue in 2016
(Reuters) — Essilor International (EPA:EI), the world’s largest maker of ophthalmic lenses, said today that operating profit rose 19.6% in 2015 and forecast that revenue would grow over the coming...
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FDA panel recommends deep, long-term monitoring for leadless pacemakers
An FDA advisory panel yesterday recommended deep, long-term surveillance of the leadless pacemakers being developed by the 4 leading companies in the cardiac rhythm management space. Medtronic...
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NuVasive wins a round in patent battle with Medtronic
NuVasive Inc. (NSDQ:NUVA) this week won a round in its long-standing intellectual property feud with Medtronic (NYSE:MDT) when a federal judge in California found that a patent covering NuVasive’s...
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Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S.
Nipro (TYO: 8086) said this week it launched its Cronus HP high-pressure over-the-wire balloon catheter and its AquaLiner II 2nd-gen hydrophilic nitinol guidewire in the U.S. The Japanese company’s...
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Pentax updates on FDA-cleared scope labeling to fight “superbugs”
The FDA said it cleared updated reprocessing instructions for Pentax’s ED-3490TK video duodenoscopes to avoid infectious outbreaks of “superbugs.” Duodenoscopes are used for a procedure called...
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AI startup MedyMatch lures ex-Philips imaging CEO Saragnese
Newly launched artificial intelligence healthcare startup MedyMatch Technology said today it snagged ex-Royal Philips (NYSE:PHG) Imaging Systems division CEO Gene Saragnese as its new chief exec and...
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MassDevice.com +3 | The top 3 medtech stories for February 19, 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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