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FDA releases May 2013 PMA approvals
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in May 2013.Summary of PMA Originals Under Review Total Under Review: 55...
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UPDATE: Medtronic drops $200M on Cardiocom
Medtronic spends $200 million to acquire disease management company Cardiocom, aiming to expand its reach into disease management.Medtronic (NYSE:MDT) bought Cardiocom LLC for $200 million in cash in a...
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U.S. FDA plans tech improvements for IDE submissions
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the...
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CAS Medical wins a legal round against Covidien's Nellcor
A federal judge tosses 1 count of a patent infringement lawsuit filed by Covidien's Nellcor subsidiary against CAS Medical over patient monitoring technology.Legal News, News Well, Patent Infringement,...
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European restructuring costs hit Q1 earnings for Steris
A more than $9 million tax charge related to the restructuring of its European operations pushes fiscal 1st-quarter earnings down for Steris Corp.Steris posts a mixed bag in Q1, strong sales and...
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MassDevice.com +3 | The top 3 med-tech stories for August 7, 2013
Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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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Second-quarter losses soar for Derma Sciences
Wound care company Derma Sciences sinks deeper into the red in the 2nd quarter, but beats Wall Street's expectations by 4¢. Second-quarter losses soared for Derma Sciences (NSDQ:DSCI), but the wound...
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Obamacare leaves autism coverage to states | MassDevice.com On Call
Autism advocates are disappointed with the Obama administration's decision to let state authorities negotiate insurance coverage for the condition.MASSDEVICE ON CALL — Advocate groups for autism, a...
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Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical...
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mHealth weight-loss app raises $18M in Series A round
San Francisco-based MyFitnessPal app developers raise $18 million in their 1st go at fundraising.MyFitnessPal, a San Francisco software developer with a namesake smartphone app, raised its 1st round of...
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Echo Therapeutics climbs back up after post-earnings share slide
Echo Therapeutics' shares slide and climb back up after the company posts a tough quarter that still beats analysts' estimates.News Well, MassDevice.com Earnings Roundup, 2013, Q2, Wall Street Beatread...
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Hacking: Diagnosing cyber-infections in medical devices
Researchers can tell if a medical device is infected with viruses or malware by identifying signatures in their power use.Researchers have developed a "behavior-monitoring system" that they say can...
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Uroplasty's new CFO hails from Synovis | Personnel Moves
Uroplasty fills its chief finance officer spot with the former CFO of Synovis, a company acquired by Baxter.Uroplasty (NSDQ:UPI) named Brett Reynolds to head its vacant finance chief position, drawing...
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Invacare sinks and rebounds on restated Q2, sale of medical recliner business
Shares of medical device maker Invacare slip after the company restates its Q2 financial report with deeper losses, but shares claw back some of their lost value after Invacare reports a divestiture of...
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FDA issues Class I recall on infusion technology made by Iradimed
The FDA put a Class I recall warning on some of Iradimed's Mridium infusion pumps based on a glitch that displays the wrong infusion dose, an error that the agency warns might lead to serious injury or...
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GE lands $10M DARPA grant to develop in-the-field infectious disease test
DARPA hands GE $10 million to continue developing a pocket-sized infectious disease diagnostic device that promises to be 'as simple as a pregnancy test.'Fueled by a $9.6 million grant from DARPA, GE...
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Jury hands Covidien's ev3 subsidiary a possible $275M loss
A Delaware state jury finds that Covidien's ev3 subsidiary broke its deal for a $175 million milestone payment to Appriva Medical, awarding the milestone nut plus interest.Covidien (NYSE:COV) is on the...
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FDA win for Given Imaging's 3rd-gen PillCam
The U.S. federal watchdog agency cleared Given Imaging's 3rd-generation PillCam, a capsule-sized camera used to diagnose GI diseases.Israel-based Given Imaging is slated to roll out its next-generation...
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GPOs: Medtronic, St. Jude, Boston Scientific land new deals from Premier
Hospital group purchasing organization Premier awards new deals to device giants including Medtronic, St. Jude, and Boston Scientific for drug eluting stents, traditional stents and other cardiac...
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Elekta, Varian settle trade theft, rep-poaching lawsuit
Rival radiological device makers Elekta and Varian Medical settle a lawsuit accusing the Swedish company of poaching sales reps and trade secrets from Varian.Legal News, News Well, MassDevice.com...
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