During the summer of 2022, we expanded into a new space to better serve our customers. This expansion included the addition of several laboratory spaces and new equipment including a C-arm unit and fluoroscopy suite.
Fluoroscopic imaging is an integral part of many minimally invasive treatments. As a result, using this imaging modality as part of testing new medical devices is an important step in ensuring user needs and design specifications are met. For example, simulated use testing in a fluoroscopy suite can aid in validating product usability. Additionally, product visibility under representative phantoms and anatomy can be verified with this clinical imaging mode.
We have experience utilizing the C-arm for simulated use deployment studies using anatomical models for tracking. These studies provide valuable information into the clinical procedure which would be performed under fluoroscopy. Information from device visibility to deployment accuracy can be acquired during a simulated use study. Images and video of these procedures can help to verify design requirements or troubleshoot issues in deployment. Additionally, we have the expertise to perform the simulated use study in a constant flow environment or a pulsatile flow environment to mimic in vivo conditions.
The radiopacity evaluation of a medical device is a crucial component to the development process as the ability to visualize the device during use is vital to successful clinical outcomes. Radiopacity testing, according to the methods described in ASTM F640, provides valuable information about the device while under fluoroscopy. For additional details regarding radiopacity testing at MED Institute, please see our white paper on radiopacity testing.
Our lab is ISO/IEC 17025 accredited for radiopacity testing. We offer both qualitative and quantitative testing in accordance with the ASTM standard F640-12. Additionally, ISO 25539-1, 25539-2, along with other ISO and ASTM standards are on MED Institute’s scope of accreditation related to simulated use testing. We can accommodate other standards as needed for your device. Our lab offers several clinically relevant body phantoms to produce images that best suit your needs and will provide you with a realistic portrayal of device visibility.
We have tools and experience to help with your radiopacity evaluation needs. Please contact us today so that we can work together to make products and therapies that will improve patient outcomes. 855.463.1633 | firstname.lastname@example.org | medinstitute.com.
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