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 […]
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 […]
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 […]
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 […]
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,” […]
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. […]
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, […]
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 […]
level to 65 percent. These changes represent significant wins for coverage and payment of innovative medical devices and are the latest in a series of payment policy victories that are the result of our multi-year advocacy efforts. Key highlights of the final rule include the following: Alternative NTAP Pathway for Breakthrough Devices and QIDPs Change […]
In an August 7 decision memo, the Centers for Medicare and Medicaid Services announced that Medicare will start covering nationwide CAR T-cell therapy for patients with certain cancers. “President Trump is committed to strengthening the Medicare program by ensuring that beneficiaries have access to new and potentially lifesaving treatments. As the first type of FDA-approved gene therapy, CAR T-cell […]
On Wednesday, a half dozen Utah life sciences companies loaded up power points, videos and sample products—from syringes and catheters to stroke technology and knee replacements—to talk with parents and students about career opportunities, as part of an evening Medical Innovations Pathways (MIP) orientation at Granite School District. Representatives from BD, Merit Medical, Nelson Labs, […]
On Wednesday, The Trump Administration announced a Safe Importation Action Plan – PDF* that outlines two potential pathways that could open the door to import lower cost drugs from Canada. However, no timeline has been specified for the plan, which will be formalized through agency rulemaking. Under Pathway 1, states, wholesalers or pharmacists could submit importation […]