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Author Archives: Denise Bell

Product Recall Prevention and Recovery: 4 Critical Steps

15 August, 2019 by James Jardine, Staff Writer, MasterControl EDITOR’S NOTE: This is one in a series of highly popular GxP Lifeline blog posts that we are republishing in order to share their important subject matter and insights with a wider audience. If a person makes a mistake, a simple apology is often enough to fix […]

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DIA Global 2019 Recap: 3 Themes Shaping the Future of Life Sciences

1 August, 2019 by James Jardine, Staff Writer, MasterControl The DIA 2019 Global Annual Meeting held June 23-27 in San Diego played host to approximately 7,000 pharmaceutical, biotechnology and medical device professionals from dozens of countries and more than 400 exhibiting providers of products and services that support the life sciences. As stakeholders gathered at […]

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Life Sciences News: 3-D Printing Cells and Moving, Feeling Prosthetic Arm

The Fine Print: University of Utah Engineers Develop Process to 3-D Print Cells to Produce Human Tissue Such as Ligaments and Tendons “’It will allow patients to receive replacement tissues without additional surgeries and without having to harvest tissue from other sites, which has its own source of problems,’ says University of Utah biomedical engineering […]

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Gary Crocker Honored at 2019-20 Bench to Bedside Launch

On Monday, September 16, 2019 the University of Utah Center for Medical Innovation kicked off its 10th Annual Bench to Bedside competition.  The Bench to Bedside program introduces students to the fascinating world of medical technology innovation.  The program has continued to grow in both scale an impact with more than 65 teams moving forward […]

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RAPS Webcast

On Wednesday October 2, Join RAPS for a 60-minute webcast offering tips, strategies and best practices for reducing barriers to approval by notified bodies. The presentation is based on lessons learned through work with dozens of organizations, across a variety of product types, that are writing CER literature reviews for regulatory submissions. Learn more and register here

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USMCA: Inside Look

On September 24, join the Commercial Service, World Trade Center Utah and the U.S. Small Business Administration (SBA) to learn how to grow and support your international business expansion into Mexico and Canada under the proposed new deal. Hear from Geri Word, Director of the Office of North America for the U.S. Department of Commerce […]

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DiscGenics Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration

Salt Lake City, UT – August 26, 2019 – DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell […]

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Sen. Mitt Romney Hosts Roundtable Discussion with Utah Life Sciences Leaders

On Monday, August 19, Senator Mitt Romney (R-UT) held a roundtable discussion with leaders from more than 30 Utah-based medical device, pharma and diagnostic companies. Held at Biomerics’ new facility, Romney first toured Biomerics with CEO Travis Sessions, then engaged in a discussion with companies on a range of federal issues impacting Utah’s growing life […]

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Vice President Mike Pence Tours Merit Medical, Talks U.S., Mexico, Canada Agreement

On Thursday, Vice President Mike Pence toured Merit Medical, where he delivered remarks to employees, local government officials and guests in support of the United States, Mexico, Canada Agreement (USMCA).  “Merit is a great example of a Utah life sciences company that is making its mark not only in the state, but around the globe,” […]

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2019 Utah Life Sciences Summit Presented by ATL Technology

The 2019 Utah Life Sciences Summit brings together thought provoking experts and key members of the life sciences ecosystem for a robust dialogue on the challenges and opportunities facing our industry, including leaders from government, academia and the investor community. Network with some of the best and brightest in the business. Build invaluable strategic contacts. […]

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Grassroots Alert: Sign the Letter to Congress to End the Medical Device Tax

The Medical Device Manufacturers Association (MDMA), along with AdvaMed and the Medical Imaging Technology Association, is circulating a letter for sign on by stakeholders who support repeal of the medical device tax. As you know, unless Congress acts, the tax will take effect January 1, 2020. MDMA spearheaded a similar broad-based coalition letter in 2009, […]

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​Breakthrough Technology – Add-On Payments for Medical Devices and Antimicrobial Drugs

In its final FY 2020 Medicare Hospital Inpatient Prospective Payment System rule released on August 2, (see fact sheet), the Center for Medicare and Medicaid Services updated payment policies for medical devices that meet the FDA’s Breakthrough Devices designation. Devices that qualify would no longer be required to demonstrate evidence of “substantial clinical improvement” to […]

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