Eu Medical Device Regulations Articles & Analysis
13 news found
Manufacturer of the revolutionary XSTAT technology will now have a second sterile wound dressing available in Europe and other International markets. RevMedx, Inc., a global leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XGAUZE wound dressing in Europe. XGAUZE, a Class I sterile ...
ByRevMedx
Please find below a letter that our attorney sent to the editors of Medscape (parent company WebMD) who have published false information about our product. Medscape Letter Regarding Avery System Avery Biomedical Devices has an outstanding track record spanning over 45 years including an outstanding safety record, long term viability with some patients pacing for more than 35 years, and ...
Avery Biomedical Devices (Commack, NY), the global leader in high reliability diaphragm pacemakers, announced that its new diaphragm pacemaker transmitter, Spirit, has earned FDA approval and is now being offered to patients using its pacing system. This NextGen transmitter features a light-weight compact design with easy-to-use touch controls and offers precision-enhancing digital ...
“The approval enables us to gain access to markets that accept CE marked medical devices, and it also sets the stage for strategic partnerships with larger manufacturers who are not ready to transition to the new EU Medical Device Regulation (MDR) that goes into effect later this ...
Newsight Imaging, an Israeli startup developing imaging solutions and chips for spectral and machine vision applications, announced today that the company’s SpectraLIT device, powered by Virusight Diagnostic’s AI software, which enables a ground-breaking 20-second COVID-19 diagnosis, has received the Conformité Européene (CE-European Conformity) Mark approval. ...
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema. The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and ...
BioQ Pharma Incorporated (“the Company”), a specialty pharmaceutical company, today announced receipt of CE mark approval in the European Union for its OneDose ReadyfusOR Gen2, single-use medication dispenser. The OneDose ReadyfusOR Gen2 is the second generation of the Company’s original OneDose ReadyfusOR infusion system and was developed to further improve patient convenience. ...
Rejoint provides the holistic approach for total knee replacement called YourKnee™ which has received the Conformité Européene (CE) Mark in January 2020. The CE marking confirms that YourKnee meets the requirements of the European Medical Devices Directive, which allows Rejoint to commercialize YourKnee and all its disposable products across the European Union and other CE ...
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first product, the BioBridge Collagen Matrix. BioBridge is classified as a Class III device with an indication for use to support lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema. CE mark is a ...
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains ...
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains a leading driver of ...
Revolutionary bleeding control technology will now be available in Europe and other International markets. RevMedx, Inc., a leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XSTAT 30 and XSTAT 12 hemostatic devices in Europe. Unlike traditional wound treatments that may take several ...
ByRevMedx
BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical ...