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FDA updates on Boston Scientific surgical mesh implant “counterfeit” material
The FDA today released an update on allegations that Boston Scientific‘s (NYSE:BSX) urogynecologic surgical mesh may contain counterfeit raw material. The agency said it was “examining these...
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Report: Ransomware attacks will increase at U.S Hospitals
A new report from a non-profit healthcare group is telling hospitals to brace for a spike in ransomware attacks, used to shut down computer networks and hold them hostage until they receive payment....
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Plaintiff’s lawyers ask FDA to ban Boston Scientific’s pelvic mesh
The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products...
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A personalized approach to treating kidney stones
One in 10 people in their lifetime will have a kidney stone — a small, hard deposit of mineral and acid salts that can obstruct the drainage of urine, cause intense pain and, if not treated properly,...
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Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients....
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Medtronic touts more early data from drug-filled stent study | ACC 2016
Medtronic (NYSE:MDT) yesterday touted early data from a clinical study of its drug-filled stent aimed at winning CE Mark approval in the European Union. The DFS is built using the Fridley, Minn.-based...
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AngioDynamics CEO DeVivo out, ex-Covidien exec Clemmer in | Personnel Moves...
1. AngioDynamics CEO DeVivo is out, ex-Covidien exec Clemmer is in AngioDynamics (NSDQ:ANGO) said today that president & CEO Joseph DeVivo stepped down to “pursue other interests” and was replaced...
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Fire & Ice: Medtronic’s Arctic Front ablation catheter as good as BioSense...
Results from a clinical trial presented today at the annual meeting of the American College of Cardiology showed that the Arctic Front ablation catheter made by Medtronic (NYSE:MDT) is noninferior to...
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FDA clears CardioFocus’ HeartLight ablation system
CardioFocus said today it won FDA premarket approval for its HeartLight endoscopic ablation system, indicated for treating drug refractory recurrent symptomatic paroxysmal AF. The approval is based on...
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ConforMIS yanks FDA clearance bid for iTotal hip, shares slide
ConforMIS (NSDQ:CFMS) shares slid today after the medical device company said it’s withdrawing its bid for FDA clearance for the iTotal personalized hip replacement after the federal safety watchdog...
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Verb Surgical CEO Heunnekens says company is focusing on “digital surgery”
Verily and Johnson & Johnson‘s (NYSE:JNJ) collaborative business Verb Surgical looks to set the stage for a new style of robotic surgery, called “digital surgery,” according to an interview with...
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FDA warns on CT risks to electronic medical devices
Getting a CT scan could result in adverse consequences for patients with insulin pumps, cardiac implantable electronic devices and neurostimulators, according to a new report form the FDA. The federal...
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MassDevice.com +5 | The top 5 medtech stories for April 4, 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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Boston Scientific’s Synergy stent at 2 years | ACC 2016 roundup
Evolve II: 2-year data for Boston Scientific’s Synergy stent Boston Scientific‘s (NYSE:BSX) Synergy stent showed non-inferiority to its Promus Element Plus device after 12 months, according to data...
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LivaNova launches Perceval valve trial
LivaNova (NSDQ:LIVN) said today the 1st patient in the Persist-AVR trial of its Perceval sutureless aortic valve was implanted with the device at Nancy, France’s University of Lorraine. The company...
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Three reasons to be optimistic about bioresorbable stents
by Eric Distad, Senior Director, Medical Device & Diagnostics, Novella Clinical In a December 2015 blog post, I quoted a report by Technavio stating that bioresorbable coronary stents would be a...
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Stakeholders question FDA’s plan to release early warning on medical devices
Industry groups are responding to the FDA’s proposal to publicly release emerging safety signals before substantiation after the agency released draft guidance explaining its plans to track and...
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Navidea to seek rheumatoid arthritis indication for Lymphoseek
Navidea (NYSE:NAVB) said today it is beginning the clinical trial development process as it seeks an indication for its Lymphoseek injection for treating rheumatoid arthritis and other disease states....
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US to pay more to insurers who provide Medicare Advantage in 2017
(Reuters) – The U.S. government will pay U.S. health insurers who provide Medicare Advantage plans to elderly and disabled Americans about 0.85 percent more on average in 2017 than in 2016, reflecting...
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The Future of the FDA: A Clinical Research Associate’s Perception
There are many stakeholders involved in conducting a clinical trial today; however there can be many challenges to the infrastructure of running a clinical trial. Challenges that are seen with running...
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