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Medical Device Directive 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 market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...
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 ...
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, ...
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 ...
NuShores is currently working on several new medical devices based on our pipeline of UALR licenses and internally developed innovations and inventions. ...
Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”) a late-stage, pre-revenue diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced that Edwin “Ed” E. Rule, has joined the Company as Vice President Regulatory, Quality and Compliance. He will report ...
XGAUZE is standard issue in selected US Armed Forces medical kits and has several hundred documented treatments since its release in 2015. Using expanding sponge technology similar to RevMedx’s XSTAT injectable device, compressed sponges embedded in XGAUZE rapidly absorb blood and expand to ten times their original size. ...
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. ...
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 exceptional patient satisfaction. It is also the only device of its kind with full FDA premarket approval and CE marking privileges ...
EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that it has received a CE Certificate of Conformity from its notified body permitting CE mark of the company’s EDG Ortho 65mm single-use electronic depth gauge in the European Union market. “This is a great achievement for EDGe Surgical on several ...
” The research paper in Molecular Neurodegeneration adds that the test’s “excellent performance” for Alzheimer’s disease (AD) diagnosis allows for “improved medical decision making and management, streamlined AD clinical trial enrollment, and better identification of who may benefit from an AD specific ...
Uscom is required to obtain regulatory approval of the China National Medical Products Administration (NMPA) for the two new specialised cardiovascular monitors prior to the commencement of sales. ...
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 ...
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. ...
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 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 ...
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. ...