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Boston Scientific, Mayo Clinic reveal hush-hush development program
Boston Scientific (NYSE:BSX) and Mayo Clinic today revealed a 3-year-old development program that has about a dozen new products in the pipeline, including a centering catheter for replacement heart...
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Jilted Fujifilm questions Toshiba on timing of medical biz sale to Canon
Fujifilm Holdings (TSE:4901), which lost out last week to Canon (NYSE:CAJ) in the race to be picked as preferred bidder for conglomerate Toshiba‘s (TYO:6502) medical device business, questioned Toshiba...
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Medical biz boosts Smiths Group’s H1 results
Smiths Group (LON:SMIN) posted better-than-expected 1st-half profits as growth at its Smiths Medical division made up for poor performance at its John Crane mechanical seals unit. Overall profits slid...
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Battelle: Medical device security baseline
The FDA, as a part of its Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, recommends that manufacturers describe how their device addresses cyber security. The...
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Japan approves the Sapien 3 heart valve from Edwards Lifesciences
Edwards Lifesciences (NYSE:EW) said today that the Japanese Ministry of Health, Labor & Welfare approved its Sapien 3 transcatheter aortic valve replacement. Irvine, Calif.-based Edwards said it...
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FDA warns SureTek on sterilization, QC issues
The FDA issued a warning letter it sent to single use device reprocessor SureTek Medical earlier this month over issues with the company’s cleaning and validation processes. The letter was in response...
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Intuitive Surgical wins FDA nod for new da Vinci Xi single-site instruments
Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared its new single-site instruments and accessories for the next-generation da Vinci Xi robot-assisted surgery device. The tools allow...
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Olympus updates reprocessing instructions for Duodenoscopes
The FDA yesterday released updated reprocessing instructions it received from Olympus (TYO:7733) in relation to its TJF-160F and TJF-160VF duodenoscopes. Olympus has been working on refining its...
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FDA: Abbott’s Mitraclip recall is Class I
The FDA today issued a Class I recall for Abbott‘s (NYSE:ABT) MitraClip device over issues in which the clip delivery system could not be detached from the clip due to a malfunction. Class I recall...
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InfoBionic wins 510(k) for next-gen MoMe Kardia cardiac monitor
Digital health startup InfoBionic said today it won FDA 510(k) clearance for its MoMe Kardia wireless cardiac remote monitoring system designed to aid in the diagnosis of cardiac arrhythmias. The...
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MassDevice.com +5 | The top 5 medtech stories for March 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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Decision Diagnostics sues J&J’s LifeScan over glucose test strip patents
Decision Diagnostics (OTC:DECN) said today its subsidiaries Decision IT and Pharma Tech Solutions filed a lawsuit against Johnson & Johnson (NYSE:JNJ) and its Lifescan divisions over patent...
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InspireMD opens $1.7 million in offerings to support embolic tech
InspireMD (OTC:NSPR) said today it is opening an underwritten public offering looking to bring in approximately $1.1 million through the sale of 1.9 million shares to support its CGuard EPS and MGuard...
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Vycor launches VBASMini brain access site
Vycor Medical (OTC:VYCO) said today it launched the VBASMini, a next-generation, smaller version of its ViewSite Surgical Access System, which are designed to provide surgeons access to brain tissue...
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A ‘roadmap’ for navigating patient advocacy
By: John J. Whyte, M.D., M.P.H. So, you and your organization have a passion for helping people and you want to work with FDA to advance your advocacy work. Are you unsure of the most effective way to...
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FDA: US medical device inspections down in 2015
The FDA said this week that it inspected fewer U.S. medical device plants last year than in 2014, but sent inspectors to more overseas facilities. The overall number of quality systems inspections fell...
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Senseonics cuts IPO by 25% to $45m
Senseonics (OTC:SENH) today cut the value of a pending public offering by 25%, to $45 million, saying it plans to float fewer shares at a lower price. Germantown, Md.-based Senseonics had planned to...
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Gecko Biomedical lands $25m for next-gen medical polymer
Gecko Biomedical said today that it raised a $25 million Series A2 round for the next-generation medical polymer it’s developing. Paris-based Gecko said the €22.5 million round was led by Sofinnova...
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CorMatrix launches U.S. tricuspid valve device trial
CorMatrix Cardiovascular said today it enrolled the 1st patient in a trial of its CorMatrix ECM tricuspid valve designed from regenerative tissue. The early feasibility trial aims to demonstrate proof...
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NuVasive nets $634m from convertible notes offering
NuVasive Inc. (NSDQ:NUVA) yesterday said it pulled down $634 million from a convertible debt offering it plans to use to buy back other notes coming due next year. San Diego-based NuVasive said the...
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