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Medical Device Regulations Articles & Analysis
39 news found
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...
BySTEMart
Protheragen-ING Lab, a well-known and reputable Good Laboratory Practices (GLP) service provider, has recently unveiled its cutting-edge medical device services. With a track record of excellence and reliability in providing high-quality services to the pharmaceutical and biotechnology industries, Protheragen-ING Lab is now expanding its offerings to include comprehensive solutions for medical ...
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 ...
The application for approval to commence VISABL-VT was submitted to the Ethics Committee at the Leipzig Heart Centre (the lead clinical site) as well as the German Federal Institute for Drugs and Medical Devices (BfArM), the German Competent Authority. Both submissions took place on September 15th. The Ethics Committee review will happen first, followed by a ...
ByImricor
For VisionQuest’s vice president and principal investigator Vinayak Joshi (PhD), the journey from idea to commercial product has led him halfway around the world. Dr. Joshi recently traveled to Malawi, Kenya, Nigeria, and Ghana as part of his efforts to commercialize ASPIRE, his device for the detection and diagnosis of malarial retinopathy. While in Africa, he met with leaders in ...
Little Rock, AR – NuShores Biosciences LLC (NuShores), founded and based in Little Rock, Arkansas, announced today that Mr. Sam Monk has accepted the position of Regulatory and Quality Manager and will move to Little Rock from the Seattle area. Mr. Monk will work closely with C-level management, research scientists, manufacturing, and our Quality and Regulatory team and services providers ...
He has extensive training and expertise in medical device regulations in the U.S. and numerous international markets. ...
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
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 ...
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 ...
“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 ...
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 ...
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 ...
The CE marking confirms that SpectraLIT meets the requirements of the European Medical Devices Directive, which will allow Newsight to commercialize the device with its operating system across the European Union and other CE Mark geographies. The SpectraLIT device is a miniature spectrometer with advanced capabilities, operated ...
Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced its operating and financial results for the fourth quarter and full-year 2020. Recent Highlights Senhance Surgical System received expanded 510(k) clearance for general ...
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 ...
The funds will be used to pursue the commercialization of Flosonics Medical’s wireless Doppler ultrasound patch in addition to new product development Flosonics Medical recently announced the close of a $14 million USD funding round led by Arboretum Ventures in partnership with existing investors iGan Partners and Genesys Capital. The Canadian medical device company headquartered in ...
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. ...
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 ...