Showing results for: medical device regulations News
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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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Medical certification obtained for the products of the Vaud startup
SteriLux passes the course of medical certification for the European market, thus demonstrating that its technology meets the most demanding standards in the field of health. Sterilizing heat-sensitive medical instruments without chemicals: this is the objective that the Vaud-based startup SteriLux has set itself since its creation in 2014. Its product, of sustainable design, uses ...
By SteriLux SA
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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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RevMedx receives CE Mark for XSTAT® injectable hemostatic devices
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 ...
By RevMedx
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RevMedx receives CE Mark for XGAUZE® self-expanding gauze.
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 ...
By RevMedx
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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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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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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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Hear from Top FDA Regulatory Experts at ACI’s 5th Annual FDA Boot Camp- Devices Edition
American Conference Institute is proud to announce that we are bringing our 5th Annual FDA Boot Camp- Devices Edition, back to Chicago on July 26-28, 2017. We specifically tailor this conference to provide regulatory professionals with in-depth coverage of current FDA law and regulations. New for this year, we have a fresh Ripped from the Headlines session, covering key developments in the FDA ...
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Peer-Reviewed Journal Publishes PrecivityAD™ Blood Test Research, Confirming Its Role in Assisting Clinicians in Alzheimer’s Diagnosis
A peer-reviewed journal has published the first research paper to state that the PrecivityAD™ blood test “can accurately identify brain amyloid status based on a single blood sample.” The research paper in Molecular Neurodegeneration adds that the test’s “excellent performance” for Alzheimer’s disease (AD) diagnosis allows for “improved medical ...
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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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Is data drift an issue for medical AI models - and what can we do about it?
While medical AI has many potential benefits, there are challenges that have not been tackled yet. One of the major challenges is the limited generalizability of many AI algorithms. Applying a medical AI algorithm that is trained in hospital A may give unexpected results when applied in hospital B. Why does this happen? Certain parameters are different between hospitals. If hospital A has Siemens ...
By Segmed, Inc.
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FDA Will Hold NanoDay Virtual Research Symposium on October 9
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product ...
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Imricor Submits for Approval to Commence VT Trial in Europe
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
By Imricor
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Biomatlante receives MDSAP Accreditation
Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers who market their products in Australia, Brazil, Canada, Japan and/or ...
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Two New Uscom Devices for China
Uscom has completed the development of two new specialised cardiovascular monitors, the “USCOM O2” and the “USCOM Basic”. The development of these two new monitors creates for Uscom a three-tier range of Uscom haemodynamic monitors for sale into China. Uscom is required to obtain regulatory approval of the China National Medical Products Administration (NMPA) for the two ...
By Uscom Ltd
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