Medical Device Quality Management Systems Conference: Speaker Interview – Ray...
Ray Garrison Senior Quality Systems Manager MEDTRONIC Why is the quality management system within the medical device industry important? Patient Safety. The QMS ensures the organization has processes...
View ArticleMedical Device Quality Management Systems Conference: Speaker Interview –...
Shilpa Batra Principal Quality Systems Specialist MEDTRONIC Why is the quality management system within the medical device industry important? There is the perception that a QMS is simply a list of...
View ArticleFDA Grants Investigational Device Exemption for Afib Study
AtriCure said has won an investigational device exemption from the FDA for a first-of-its-kind clinical trial involving patients with non-paroxysmal atrial fibrillation, according to MassDevice. The...
View ArticleU.S. antitrust waiting period ends for Becton Dickinson-CareFusion deal
Becton Dickinson’s $12.2 billion bid for CareFusion has cleared the required waiting period under US anti-trust regulations, according to MassDevice.com. CareFusion shareholders must still approve...
View ArticleStryker Unveils New New European HQ
Medical device giant Stryker has unveiled its new European headquarters in Amsterdam as part of its plan to boost market share in Western Europe, according to MassDevice.com. For more information,...
View ArticleRobotic Exoskeleton for Paralysis Now FDA-Approved
Those who are paralyzed now have the opportunity to use a newly-approved robotic exoskeleton called The Rewalk, which will assist in standing, walking, and offer a variety of other health benefits....
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The 6 Key Digital Marketing Options That All Medical Device Companies Need to...
Digital marketing is taking over the medical device industry and companies are tirelessly creating mobile apps, sales tools, and training programs to better equip their sales teams. But are these...
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Brookings Releases $250M Plan for Medical Device Tracking
The Brookings Institution has released a $250M plan for a postmarket medical device tracking system, under an arrangement with the FDA. According to FedScoop.com, “under the plan, the National Medical...
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Wearable Health Devices Making Big Impact in 2015
From activity trackers to more sophisticated neurostimultor devices, wearable health devices are creating exciting opportunities in medtech. According to MDDIonline.com, “Pegged at $2 billion in 2013,...
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FDA Issues Final Guidance for Labeling and Instructions for Reprocessed Med...
According to MassDevice.com, “The US Food and Drug Administration has released final guidance on how manufacturers of reusable medical devices should validate instructions for these products.” Four...
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FDA Examining Med Device Risk Assessments in Postmarket Settings
The FDA will host a public meeting on April 21 to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise in the postmarket...
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CSA Medical raises another $4m for cryotherapy device
According to MassDevice.com, “Maryland’s CSA Medical said last week that it’s close to reaching a $4 million funding goal with a new debt offering. The Baltimore-based medical device company raised...
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Zimmer and Biomet Products Acquired by Lima for EU Markets
“Lima Corporate has acquired the Zimmer Unicompartmental High Flex Knee and the Biomet Discovery Elbow System within the European Economic Area and Switzerland markets” according to an article via...
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ICYMI: US FDA Explains Criteria for Accepting Medical Device Clinical Data...
“New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and...
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How Safe Are These Medical Devices?
Recently, several medical devices have been the subject of negative headlines due to operation flaws or effectiveness. MDDIonline.com has compiled a list of medical devices that have been on the...
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After Shark Tank Defeat, 15-Year-Old Unveils New Device to Remotely Deliver...
When 15-year-old Brooke Martin went on the popular TV show Shark Tank with her dog treat dispenser ICPooch, she walked away without a deal, but with another big idea. Martin adapted her technology to...
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Five Measures for Getting the Most Out of Med Device Testing
Medical Device testing is constantly evolving, requiring more care to maintain accurate responses. According to an article via cigniti.com, five key factors play a major role when it comes to ensuring...
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Patient Opinions on Devices Important to FDA
“New draft guidance from FDA gives industry more clarity on what patient perspective information can be considered for agency review, how best to collect this data, and how to incorporate the...
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Companion Diagnostics: How Pharma and Biotech Medical Device Companies are...
“Companion Diagnostics are medical tests that identify patients within a disease category who are most likely to positively respond to a particular drug, given that they have the exact molecular defect...
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Two Boston-area medical device firms get $26M investment
According to the Boston Business Journal, “Two co-located Watertown companies that got a new CEO earlier this year have together raised $26.5 million in debt and equity financing to fund development of...
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