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INDUSTRY EXPERT ARTICLES
Medical Device News is a magazine that publishes feature articles from industry experts on medical device technology, regulation, reimbursement, and business strategy.
A Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices
In 1976, Congress passed the Medical Device Amendments (MDA) to charge the FDA with reviewing the safety and effectiveness of medical devices. The MDA heavily regulates high-risk medical devices that are capable of supporting human life through a premarket approval process. Read what a litigation associate in BakerHostetler’s Houston office advises.
Growing Trends and Solutions for Improving Liver Health Management
Author Jon Gingrich, CEO, Echosens North America writes, "Nonalcoholic fatty liver disease (NAFLD) is an asymptomatic and underdiagnosed disease that affects 37% of U.S. adults and 70% of individuals with Type 2 diabetes. Nonalcoholic steatohepatitis (NASH), the more severe form of NAFLD marked by inflammation and ballooning, can lead to hepatic fibrosis, cirrhosis, and hepatocellular cancer (HCC) if left untreated." Read more.
How COVID-19 Has Spurred A Shift to Broad-Spectrum Countermeasures Against Viruses
James A. Joyce writes, "On March 24, 2020, the U.S. Department of Health and Human Services declared that the emergence of COVID-19 justified the Emergency-Use Authorization of drugs, biological products, and medical devices to combat the pandemic. Read what he has to say.
Exploring the Future of Bluetooth Hearing Aids
Pauline Dinnauer is the VP of Audiological Care at Connect Hearing, which provides industry-leading hearing loss, hearing testing, and hearing aid consultation across the US. Read what she has to say.
Jesper Jonsson Interview – Concrete Action for Climate Change
Jesper Jonsson, Director of Medical Devices at Owen Mumford shares his thoughts on last year’s key sustainability topics and outlines how Owen Mumford is developing its own sustainability commitments. Read on.
The FDA Just Approved Remote Care For Cochlear Implants: Here’s What That Could Mean for You
Cochlear Limited has officially announced FDA approval and clearance for remote assist capabilities on several of its implants. Here's what that means for you. Dr. Renee Flanagan is the Director of Audiological Care at Hearing Planet. Read more about what she has to say,
How Simulation is Revolutionizing Surgery for Both Surgeons and Patients
by Raimundo Sierra, Ph.D., Co-Founder, VirtaMed. He writes, "As the world continues to advance technologically, medical education must follow suit."
Escaping the “Valley of Death”— The Funding Process for Biotechnology Companies
Innovative biotechnology companies have the potential to transform healthcare, developing new therapies that may improve, as well as extend, the lives of patients. Delivering on this promise is an epic journey that may take one to two decades, unimaginable amounts of cash, and surviving the notorious valley of death. Read what Christopher J. Calhoun, Chairman & CEO of PARACRINE has to say.
3D Imaging Software: The Future of Shoulder Arthroplasty in the Digital Era: By Brent Narkiewicz VP of Catalyst
To meet burgeoning market demands and accelerate growth, med-tech partnerships that enable the use of 3D imagining software have become critically important. Indeed, this technology is increasingly considered an essential tool for today’s arthroplasty surgeons. Read Brent Narkiewicz VP of Catalyst's views.