• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » St. Jude’s Ilumien hybrid wins CE Mark | Regulatory Roundup

St. Jude’s Ilumien hybrid wins CE Mark | Regulatory Roundup

July 14, 2011 By MassDevice staff

Regulatory Roundup

St. Jude Medical Inc. (NYSE:STJ) landed CE Mark approval in the European Union for what it bills as the first and only hybrid diagnostic imaging system to combine optical coherence tomography and fractional flow reserve technology into a single platform.

The Ilumien system combines a wireless tool that measures the severity of blood flow blockages in coronary arteries and OCT imaging technology that allows physicians to visualize and measure blood vessels. The device also wirelessly transmits pressure readings from the instrument within the blood vessel to the external monitor.

"Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies," said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division, in a press release. "We believe integrating these technologies is key to providing physicians a simplified, streamlined option for the diagnosis and treatment of patients with coronary artery disease."

  • Sequana lands CE Mark for low-flow bladder pump
    Sequana Medical, which changed its name from NovaShunt AG last month, announced today that it won CE Mark approval for its low-flow bladder pump, which removes excess abdominal fluid in patients suffering from liver disease.

    "This is a major milestone both for our company and for patients with refractory ascites," stated Dr. Noel Johnson, CEO of Sequana Medical. "For patients, the treatment options for refractory ascites have been very limited and carried significant risks and side effects. The ALFApump System offers a new treatment tool which can improve patient quality of life while also reducing hospitalizations. It is a cost-effective solution and we believe over time it will become the preferred option for patients, physicians and payers. We are eager to begin our commercial launch in Europe."

    Read more

  • ActiViews gets FDA clearance for needle guidance system
    Wakefield, Mass.-based ActiViews Inc. landed clearance from the U.S. Food & Drug Administration for its CT-Guide needle guidance system for lung intervention treatments. The device is an accessory for CT scanners and uses a single-use mini-video camera that attaches to standard interventional instruments. It creates 3D images on a HD flat panel monitor mounted on a mobile workstation to help physicians navigate instruments in relation to the spatial location within the lungs and the desired target.

    Read more
  • Guided Therapeutics updates on PMA bid
    Guided Therapeutics Inc. (OTC:GTHP) has one last question to answer in its pre-market approval application for the LuViva biophotonic testing platform for detecting cervical cancer. The company, which held initial meetings with the FDA in April, expects no problems in fulfilling the agency’s final request and plans to launch the device in late 2011 or early 2012.
    Read more
  • Edwards Lifesciences gets FDA nod for clinical monitoring system
    Edwards Lifesciences Corp. (NYSE:EW) announced FDA 510(k) clearance for its EV1000 clinical monitoring platform, which features a touch-screen monitor that displays patient information, clinical targets and alerts.

    "We look forward to offering this sophisticated technology to clinicians and their patients in the U.S. and to integrating our current and expanding portfolio of catheters and sensors onto this platform," said Carlyn Solomon, corporate VP of critical care.
    Read more

  • Filed Under: News Well Tagged With: ActiViews Inc., Edwards Lifesciences, Guided Therapeutics Inc., NovaShunt AG, Sequana Medical AG, stjudemedical

    More recent news

    • Cognixion, Blackrock Neurotech ink distro deal for BCI tech
    • AdvaMed calls for medtech tariff exemptions at Senate hearing
    • GE HealthCare, Raydiant Oximetry partner on fetal oxygen saturation tech
    • Terumo Neuro launches new stroke catheter in the U.S.
    • EnVVeno has first-in-human heart valve data, expects FDA decision this year

    Primary Sidebar

    “md
    EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
    Get the latest med device regulatory, business and technology news.

    DeviceTalks Weekly

    See More >

    MEDTECH 100 Stock INDEX

    Medtech 100 logo
    Market Summary > Current Price
    The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
    MDO ad

    Footer

    MASSDEVICE MEDICAL NETWORK

    DeviceTalks
    Drug Delivery Business News
    Medical Design & Outsourcing
    Medical Tubing + Extrusion
    Drug Discovery & Development
    Pharmaceutical Processing World
    MedTech 100 Index
    R&D World
    Medical Design Sourcing

    DeviceTalks Webinars, Podcasts, & Discussions

    Attend our Monthly Webinars
    Listen to our Weekly Podcasts
    Join our DeviceTalks Tuesdays Discussion

    MASSDEVICE

    Subscribe to MassDevice E-Newsletter
    Advertise with us
    About
    Contact us

    Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
    The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

    Privacy Policy