Alert

FDA Restricts Sale of Bayerā€™s Essure

By MedTech Intelligence Staff

…before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.” – FDA According to an FDA news release, since…

…before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.” – FDA According to an FDA news release, since…

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Laura Johnson, Loftware
Soapbox

Emerging Trends and Opportunities in Medical Device Labeling

By Laura Johnson

…some new industry trends in labeling that are also providing unique opportunities for companies to reduce costs, save time, improve time to market (i.e., gain a competitive advantage). Here are…

…some new industry trends in labeling that are also providing unique opportunities for companies to reduce costs, save time, improve time to market (i.e., gain a competitive advantage). Here are…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Risk-Based Purchasing Controls

By Dr. Christopher Joseph Devine

…appropriately validated. For example, device packaging modalities and sterilization methods shall be appropriately validated before they can be considered for use. Takeaways For this week’s guidance, the doctor will leave…

…appropriately validated. For example, device packaging modalities and sterilization methods shall be appropriately validated before they can be considered for use. Takeaways For this week’s guidance, the doctor will leave…

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MedTech Intelligence

Cybersecurity: How Vulnerable Are You?

By MedTech Intelligence Staff

Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies….

Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies….

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Sue Niemeier, Ivenix
MEDdesign

When Accuracy and Flow Donā€™t Add Up: The Case for New Design in Large Volume Pumps

By Susan Niemeier, MHA, BSN, RN

…to ensure the highest quality patient care and safety. This starts with adaptive pump technology. An adaptive pump system automatically compensates for external factors that impact fluid delivery and will…

…to ensure the highest quality patient care and safety. This starts with adaptive pump technology. An adaptive pump system automatically compensates for external factors that impact fluid delivery and will…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

When Furry Critters Arenā€™t So Cute

By Dr. Christopher Joseph Devine

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Dr. D’s enforcement page. (February 2016). DGII Website. Accessed March 27, 2018. Retrieved from http://www.devineguidanceinternational.com

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Dr. D’s enforcement page. (February 2016). DGII Website. Accessed March 27, 2018. Retrieved from http://www.devineguidanceinternational.com

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FDA

FDA Allows Marketing of First Interoperable Continuous Glucose Monitoring System

By MedTech Intelligence Staff

…click on each story for the update. You can also sound off in the comments section. Think this is the fake news? Wrong! Here’s our April Fool’s story. https://medtechintelligence.com/column/when-furry-critters-arent-so-cute/  …

…click on each story for the update. You can also sound off in the comments section. Think this is the fake news? Wrong! Here’s our April Fool’s story. https://medtechintelligence.com/column/when-furry-critters-arent-so-cute/  …

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Rice University, Diabetic foot

Device Helps Patients Detect Early Signs of Ulceration

By MedTech Intelligence Staff

…the photo. Images are then transferred to the website via a special computer called an onboard Raspberry Pi computer. “It’s much easier than a manual device, like a mirror on…

…the photo. Images are then transferred to the website via a special computer called an onboard Raspberry Pi computer. “It’s much easier than a manual device, like a mirror on…

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Medical device recall

BD Recalls Vacutainer Blood Collection Tubes Due to Chemical Interference

By MedTech Intelligence Staff

…with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology (used in Magellan Diagnostics’ LeadCare Testing Systems). Last week BD sent an Urgent Medical Device Correction Notice to affected…

…with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology (used in Magellan Diagnostics’ LeadCare Testing Systems). Last week BD sent an Urgent Medical Device Correction Notice to affected…

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Daniel R. Matlis, Axendia
Soapbox

Why Is Quality Focusing on Compliance?

By Daniel R. Matlis

…and engineering systems will be best situated to meet patient needs. To compete in today’s global markets, medical device companies must shift to modern, closed loop, product development approaches. They…

…and engineering systems will be best situated to meet patient needs. To compete in today’s global markets, medical device companies must shift to modern, closed loop, product development approaches. They…

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