Latest Headlines

  1. Abbott Diagnostic Assay Authorized To Test Whole Blood Samples For Zika Virus
    2/6/2017

    Abbott announced that the FDA has extended the company’s Emergency Use Authorization (EUA) for a Zika virus assay to include use with whole blood samples, making it the only diagnostic to receive such an expanded designation. 

  2. Alesi Surgical’s Surgical “Smoke” Clearing System Gains FDA Clearance
    2/6/2017

    Alesi Surgical Limited, the leading innovator of minimally invasive surgery technologies has successfully secured FDA (Food and Drug Administration) approval for its Ultravision system.

  3. Merit Medical Pays $48M For Product Lines From Argon, Catheter Connections
    2/6/2017

    Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that it has acquired certain products from Argon Medical Devices and Catheter Connections, Inc. 

  4. FDA Accepts Intarcia’s NDA For Implantable Mini-Pump
    2/3/2017

    Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug Application (NDA) for ITCA 650, an investigational therapy for the treatment of type 2 diabetes (T2D). Intarcia looks forward to working closely with the FDA through the review process

  5. Spinal Simplexity’s Minuteman Implant Gains FDA Clearance
    2/3/2017

    Spinal Simplicity, a medical device company developing innovative solutions to treat complex surgical problems, has received its third 510(k) clearance from FDA for the Minuteman G3-R spinal implant, part of the Minuteman family of supplemental fusion and fixation devices.

  6. Gore’s Balloon Stent Graft First To Gain FDA Approval For PAD In Iliac Artery
    2/2/2017

    FDA announced approval of W.L. Gore & Associates’ expandable balloon stent graft for treatment of peripheral artery disease (PAD) lesions in the iliac artery and at the aortic bifurcation. It is the first technology of its kind approved for this expanded indication.   In clinical studies, the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) demonstrated immediate and nine-month safety and efficacy endpoints in a variety of challenging peripheral artery disease (PAD) presentations.

  7. Is Medtronic Selling Its Medical Supplies Business?
    2/2/2017

    Medtronic, the world's largest pure-play medical device company, is reportedly in the early stages of selling part or all of the legacy medical supplies business it acquired through its purchase of Covidien more than two years ago.

  8. Ophir Expands Series Of Precisely Calibrated Integrating Spheres For Divergent Beams
    2/1/2017

    MKS Instruments, Inc. recently announced new additions to the Ophir® Integrating Sphere series of products. Designed for measuring divergent and collimated light sources, such as laser diodes and LEDs, the Ophir Integrating Spheres are integrating sphere and photodiode sensor systems for measuring the optical power of divergent, narrowband light sources. The series includes three precisely calibrated spheres that measure powers from 20nW to as high as 30W.

  9. Senate Democrats Boycott Committee Hearing For Trump’s HHS Nominee
    2/1/2017

    In a surprise move that “shocked” Senate Republicans, Senate Democrats boycotted committee hearings for both the nominee for Treasury secretary and the director of Health and Human Services (HHS), citing unanswered questions regarding the nominees’ personal finance decisions and possible insider trading.  Democrats claim that HHS nominee Rep. Tom Price (R-Ga.) received “privileged” information — a claim the company disputes — and bought discounted stock in an Australian biomedical company, contradicting his testimony at Senate hearings in January.

  10. Zimmer Biomet Will Diversify Offerings, Fix Supply Chain In 2017
    2/1/2017

    Zimmer Biomet will offer an expanded product portfolio and fix product supply chain woes in 2017, as the company tries to build on solid revenue growth in the fourth quarter of 2016.