European medical device regulations News
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YourKnee by Rejoint has received the Conformité Européene (CE) Mark
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 ...
By Rejoint SRL
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Avery Biomedical Letter to Medscape Regarding Diaphragm Pacing
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 ...
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BioQ Pharma Receives CE Mark for Third Infusion System
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. ...
By BioQ Pharma
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V-Wave receives second FDA breakthrough device designation: interatrial shunt for pulmonary arterial hypertension
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 ...
By V-Wave Ltd.
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V-Wave Receives CE Mark for the Ventura Interatrial Shunt System
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 ...
By V-Wave Ltd.
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BSI group America Inc. Announces specialized regulatory training courses for the healthcare industry
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 Device Directive enabling attendees to comply efficiently with ...
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Newsight Imaging Announces CE Mark Approval for SpectraLIT 20-Second COVID-19 Diagnosis
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. ...
By Virusight
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Fibralign Announces CE Mark Approval for BioBridge
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 ...
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Fibralign Announces Start of European Lymphedema Prevention Clinical Study
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 ...
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Avery Biomedical Devices’ Nextgen Diaphragm Pacing Transmitter, Spirit, Earns FDA Approval – Now Available
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 ...
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