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    Breaking News

    Siemens Healthineers Receives FDA Clearance for ARTIS icono Angiography Systems

    The product family is designed to improve lab utilization and interdisciplinary usage.

    Business Wire10.25.19
    The U.S. Food and Drug Administration (FDA) has cleared the ARTIS icono, a high-precision family of angiography systems from Siemens Healthineers that permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal utilization in neuroradiology and abdominal imaging, while the ARTIS icono floor is a floor-mounted, single-plane system for vascular, interventional cardiology, surgical, and oncology procedures. Both systems in the ARTIS icono family expand the reach of precision medicine.
     
    At its core, the ARTIS icono platform delivers the new OPTIQ image chain, which fundamentally redesigns image processing for 2D imaging. OPTIQ increases image quality across a wide range of C-arm angles and patient weights, regulating acquisition parameters to automatically achieve optimal image contrast at patient radiation doses that conform to the As Low As Reasonably Achievable (ALARA) guiding principal for radiation safety. The platform also improves the Siemens Healthineers roadmap function, which creates subtracted angiography images for easier navigation of the patient’s vascular system during subsequent fluoroscopy, allowing dose reduction during the fluoro mode.
     
    Additionally, the ARTIS icono platform significantly enhances ease of use through Case Flows, which provide personalized workflow plans to optimize imaging parameters and system positions, in addition to displaying layouts for the entire procedure. Case Flows adapt to user needs, providing flexibility when executing certain sequences. Users can therefore standardize procedures across multiple ARTIS icono labs for improved outcomes and more consistent documentation.
     
    The ARTIS icono biplane system is engineered for superior utilization in neurointerventions and interventional radiology, with significantly enhanced 2D and 3D imaging as well as improved visualization of difficult-to-delineate structures.
     
    Recent studies have expanded the window for endovascular stroke therapy from six to 24 hours, offering the option of treating more ischemic stroke patients. Stroke treatment and other neuro procedures benefit from new features on the ARTIS icono biplane. A revolutionary form of cone beam CT, syngo DynaCT Sine Spin provides images with fewer cone beam CT artifacts in the basal part of the brain and close to the skull. syngo DynaCT Multiphase produces time-resolved cone beam CT volumes, depicting 10 different time points within 60 seconds without moving the patient to a CT system.
     
    Additionally, syngo DynaCT High Speed can substantially shorten low-contrast 3D imaging from 20 seconds to eight to deliver CT-like images that are less susceptible to movement artifacts. The Twin Spin feature enables clinicians to seamlessly switch between 2D biplanar imaging and 3D imaging, accelerating workflow and simplifying 3D imaging for intraprocedural progress checks.
     
    The ARTIS icono biplane also provides rapid flexibility for multidisciplinary lab use. With the Lateral Plane Switch, the user can shift the detector’s position from the patient’s right side (for interventional radiology procedures) to the left side (for cardiovascular procedures) in under 90 seconds.
     
    The ARTIS icono floor is a flexible, multi-axis floor system created for a wide range of disciplines, particularly vascular, interventional cardiology, surgical, and interventional oncology. With ceiling-like flexibility and a footprint of just 269 square feet, it provides coverage of patients up to 6 feet, 8 inches without repositioning, as well as lateral coverage of 6.23 feet, which is ideal for radial access. With its additional axis, the ARTIS icono floor can achieve virtually the same angles as a ceiling-mounted system and free space for anesthesia carts, echocardiography systems, and patient monitors without the cost of a ceiling-mounted unit.
     
    “The ARTIS icono family of angiography systems will have nothing short of a revolutionary impact on our customers and on the delivery of healthcare in general, by setting new standards for image quality and optimized workflow in minimally invasive procedures,” said Lara Barghout, senior vice president and head of Advanced Therapies, Siemens Healthineers North America. “And as more hospitals introduce comprehensive stroke services to treat more patients who are eligible for thrombectomies, the ARTIS icono biplane raises the bar in consistent 3D image quality for whole-brain imaging.”
     
    Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers innovates its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2018, which ended Sept. 30, 2018, Siemens Healthineers generated revenue of 13.4 billion euros and adjusted profit of 2.3 billion euros and has about 50,000 employees worldwide.
     
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    • FDA Encourages Patient Engagement in Medical Device Clinical Investigations

      FDA Encourages Patient Engagement in Medical Device Clinical Investigations

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    • FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)

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      U.S. Food and Drug Administration 09.20.19

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