By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
China issues new procedures for medical device registration
By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its […]
Tandem Diabetes Care wins expanded FDA indication for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]
How EU MDR and human factors affect design user-friendly software user interfaces
By Kimmy Ansems and Linda Giesselink, Emergo Group Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices. In the fourth blog post in our series on the European Medical Devices Regulation (MDR) and human factors engineering, we reference various MDR General […]
Medtronic lands CE Mark for MiniMed 780G insulin pump
Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its MiniMed 790G next-generation insulin pump. The closed-loop insulin pump system is indicated for treating Type 1 diabetes in people aged 70 to 80 years old. It uses Medtronic’s SmartGuard algorithm to automate the delivery of basal insulin and correction boluses every five […]
MDR delay impact extends beyond European Union
By Timothy Herr, Emergo Group While we have reported on the one-year delay of Europe’s Medical Devices Regulation (MDR) due to the COVID-19 pandemic, we have not yet touched on the ramifications that this decision has on countries outside the European Union. The United Kingdom and the nations of the European Free Trade Association (EFTA) […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Baxter wins CE Mark for EVO IQ syringe system
Baxter (NYSE:BAX) announced that it received regulatory approval in Europe and Australia for its Evo IQ syringe infusion system. With CE Mark approval in Europe and a nod from Australia’s Therapeutic Goods Administration (TGA), the company expects hospitals in the United Kingdom, Ireland, Greece, Australia and New Zealand to be among the first to receive the […]
Eudamed updates phased implementation for European medical device, IVD database
By Ronald Boumans, Emergo Group The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official […]
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