Forefront Medical Technology

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  • Mike on Medtech: The Special 510(k) Program

    Mike on Medtech: The Special 510(k) Program

    Mike Drues and Sean Fenske discuss a 510(k) option for modifications to a company's legally marketed medical device.
    Sean Fenske, Editor-in-Chief 11.13.19

  • Cardiovascular | Neurological
    Anaconda Biomed Completes First-in-Human Study of Thrombectomy System

    Anaconda Biomed Completes First-in-Human Study of Thrombectomy System

    Trial Data will support regulatory submission to FDA.
    Business Wire 11.05.19

  • 3D/Additive Manufacturing | Surgical
    The Wide World of 3D Printing for Medtech

    The Wide World of 3D Printing for Medtech

    In this interview with Guangmei Wu of Johnson & Johnson, she shares insights into the successes and challenges surrounding 3D printing in healthcare.
    Sean Fenske, Editor-in-Chief 10.31.19


  • Fiasp Approved for Use with the Omnipod System in the U.S.

    Fiasp Approved for Use with the Omnipod System in the U.S.

    An ultra-fast-acting insulin developed by Novo Nordisk.
    Insulet Corporation 10.29.19

  • Cardiovascular
    FDA Grants ‘Breakthrough Device Designation’ to Fully Implantable Heart Pump

    FDA Grants ‘Breakthrough Device Designation’ to Fully Implantable Heart Pump

    The device is designed for patients with advanced heart failure.
    Medtronic 10.29.19

  • Packaging & Sterilization
    Top Surgeons Write Letter to the FDA

    Top Surgeons Write Letter to the FDA

    Stress the importance of Ethylene Oxide for medical device sterilization.
    AdvaMed 10.25.19


  • Cardiovascular
    Corvia Medical

    Corvia Medical's Shunt Device Receives Breakthrough Device Designation

    May reduce symptoms and slow the progression of heart failure.
    PRNewswire 10.09.19

  • Cardiovascular
    Medtronic Stent Graft System Receives FDA Breakthrough Device Designation

    Medtronic Stent Graft System Receives FDA Breakthrough Device Designation

    Developed to treat thoracoabdominal aortic aneurysm.
    Globe Newswire 10.08.19

  • Neurological
    Highmark Interactive Receives FDA Clearance for Gamified Neurological Testing Platform

    Highmark Interactive Receives FDA Clearance for Gamified Neurological Testing Platform

    ‘EQ Brain Performance’ is a tool that addresses cognitive, visual and balance performance.
    Highmark Interactive 10.08.19


  • Surgical
    Top 10 Health Technology Hazards for 2020

    Top 10 Health Technology Hazards for 2020

    The new report identifies safety issues and action steps for 10 dangerous and preventable hazards.
    ECRI Institute 10.07.19

  • Neurological
    Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA

    Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA

    Pending approval, the devices could be available Spring 2020.
    Medtronic plc 10.07.19

  • Cardiovascular | Diagnostics
    FlowMet-R Gets FDA 510K Clearance

    FlowMet-R Gets FDA 510K Clearance

    Non-invasive blood flow monitoring device.
    PRNewswire 10.02.19


  • IP Protection: Four Areas to Audit in Selecting A Contract Manufacturer

    IP Protection: Four Areas to Audit in Selecting A Contract Manufacturer

    Intellectual property (IP) is the core of competitive advantage. When products are outsourced, the contract manufacturer performing the final assembly typically has access to the complete documentation package for the products they build. Where ar…

  • Investment Banker Appointed to BioSig Board of Directors

    Investment Banker Appointed to BioSig Board of Directors

    Newest member brings to BioSig over 30 years of experience in investment banking and medical technology.
    BioSig Technologies Inc. 08.12.19

  • Reliability is Everything

    Reliability is Everything

    Medical technology is a key market for maxon. Many of our drives are used in insulin pumps. What exactly do our motors do in these devices? To find out, we went to visit Ypsomed, a leading manufacturer of insulin pumps. DOWNLOAD TO LEARN MORE>&…

  • A Spotless Room

    A Spotless Room

    Medical technology has no tolerance for error. This is why maxon micromotors are made in certified cleanrooms. This kind of special facility takes significant effort to build. DOWNLOAD TO LEARN MORE >>>>…

  • Molding
    Mack Prototype Investing in Five New Presses

    Mack Prototype Investing in Five New Presses

    Company is retiring several 25-year-old machines.
    Mack Molding 07.30.19

  • Neurological
    INSIGHTEC Gains FDA Nod & CE Mark for Exablate Neuro with GE SIGNA Premier MR System

    INSIGHTEC Gains FDA Nod & CE Mark for Exablate Neuro with GE SIGNA Premier MR System

    The Exablate Neuro is a focused ultrasound platform for treating deep in the brain with no surgical incisions.
    PR Newswire 07.11.19

  • Molding
    Cast in a Different Mold: A Medical Molding Roundtable

    Cast in a Different Mold: A Medical Molding Roundtable

    This mainstay in medical manufacturing is subject to material and technology advances as well as competition from newer fabrication methods.
    Sam Brusco, Associate Editor 06.13.19

  • Contract Manufacturing
    Outsourcing and Trade Policies: Navigating a Complex Issue

    Outsourcing and Trade Policies: Navigating a Complex Issue

    The goals for medical contract manufacturing run the gamut from simply finding a lower cost source for building products to finding a partner capable of supporting entry into markets where a device manufacturer has no physical presence. To best deter…
    Walter Tarca, President, Forefront Medical Technology 06.13.19