Regulatory News

  1. GE’s SIGNA Premier 3.0 MRI Cleared By FDA

    GE Healthcare is proud to announce SIGNA Premier, a new wide bore 3.0T magnetic resonance imaging (MRI) system, is now available for sale in the U.S. SIGNA Premier is the result of a four-year collaboration with the National Football League (NFL) and research institutions around the world working to design new imaging tools, particularly to aid researchers in the detection of biomarkers for the potential diagnosis of mild Traumatic Brain Injury.

  2. Medtronic’s Avalus Surgical Aortic Valve Gains FDA, CE Mark Approval

    Medtronic plc recently announced CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease.

  3. Immunalysis’ Fentanyl Urine Drug Screening Test Cleared By FDA

    Immunalysis Corporation, a division of Alere Inc. (NYSE: ALR), today announced that its SEFRIA™ Fentanyl Urine Enzyme Immunoassay has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the qualitative detection of fentanyl in urine.

  4. Medtronic’s CoreValve Evolut PRO TAVR Gains CE Mark, Launches In EU

    Medtronic plc recently announced CE (Conformité Européenne) mark and European launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery

  5. Quantitative Insights’ QuantX Advanced Computer-Aided Diagnosis Platform Earns FDA De Novo Approval

    Quantitative Insights, Inc. (QI) recently announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantX Advanced system, the industry’s first computer-aided diagnosis platform incorporating machine learning for the evaluation of breast abnormalities.

  6. FDA Clears First Neonatal Magnetic Resonance Imaging Device

    Recently, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).

  7. FDA Clears Philips’ Wearable Light Therapy Device For Psoriasis

    Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Philips BlueControl wearable light therapy device to treat mild psoriasis.

  8. Stryker’s MultiGen 2 RF Generator Cleared BY FDA

    Stryker announced today that it has received FDA 510(k) clearance for its MultiGen 2 RF Generator. This product provides physicians with the efficiency, control and reliability they need when performing radiofrequency ablation, a minimally invasive procedure that can provide lasting relief to those suffering from facet joint pain.1

  9. FDA Approves Medtronic’s CoreValve Evolut TAVR For Expanded Indication

    Medtronic plc recently announced the expanded U.S. Food and Drug Administration (FDA) approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

  10. Cerus Endovascular’s Neurovascular Systems Earns CE Mark Approval

    Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System™ for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU).