Latest Headlines

  1. EarlySense, American Well Partner On Telehealth Services Powered By Smart Sensors
    1/3/2017

    EarlySense, the market leader in contact-free continuous monitoring solutions, announced today a new partnership with American Well, the nation's leading telehealth technology company.

  2. J&J’s DePuy Synthes Acquires Interventional Spine’s Expandable Cage Technology
    1/3/2017

    DePuy Synthes Products, Inc., part of the Johnson & Johnson Family of Companies, announced today an asset purchase and development agreement with Interventional Spine, Inc., a privately held manufacturer of expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion.

  3. FDA Clears Qardio’s Wearable ECG Monitor
    1/3/2017

    Qardio, Inc., the award-winning digital health company today announced that its highly anticipated product, QardioCore, a revolutionary wearable ECG monitor, is now available for pre-order at www.getqardio.com.

  4. FDA Issues List Of Priority Device Guidances For 2017
    12/29/2016

    The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114).

  5. Intarcia Raises $202M, Partners With Gates Foundation On HIV Prevention
    12/29/2016

    Intarcia Therapeutics, Inc., recently announced it has completed its second major close of the Series EE equity financing, and also entered into a relationship with the Bill & Melinda Gates Foundation to help prevent the spread of HIV in Sub-Saharan Africa and other countries where the HIV epidemic is most severe.

  6. U.S. Regulators Set To Approve St. Jude Acquisition By Abbott
    12/28/2016

    U.S. anti-trust regulators are set to approve the $25 billion acquisition of St. Jude Medical by Abbott Laboratories, according Reuters sources. The deal was approved by European regulators in November, contingent on the companies’ divestment of two cardiovascular devices to Terumo.

  7. FDA Clears Precision Spine’s Lateral Plating System
    12/27/2016

    Precision Spine, Inc. announced today that it recently received 510(k) clearance of its AccuFit Lateral Plating System. The AccuFit Plate represents a significant addition to the Precision Spine lateral product portfolio and joins the recently introduced MD Vue Lateral Access Retractor.

  8. FDA Expands Indication For Dexcom's G5 CGM For Insulin Dosing
    12/27/2016

    The U.S. Food and Drug Administration (FDA) is permitting the use of Dexcom's G5 Mobile Continuous Glucose Monitoring (CGM) System for insulin dosing without additional finger pricking, making the G5 the first device of its kind to be granted such an approval.

  9. Avacen Medical’s Fibromyalgia Pain-Relief Device Earns CE Mark
    12/23/2016

    AVACEN Medical (AVACEN) announced its AVACEN 100, Class-IIa, OTC medical device has received the CE (Conformité Européenne) Mark approval to treat widespread pain associated with fibromyalgia.

  10. Avinger’s Touchscreen Lumivascular Imaging Console Cleared By FDA
    12/23/2016

    Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console.