Tag Archives: FDAcopilot

In Washington, there are ongoing developments concerning a federal rule that intends to simplify the reimbursement process for breakthrough medical devices. This rule is anticipated to be finalized early this summer according to Dora Hughes, the director of the clinical standards center at the Centers for Medicare and Medicaid Services (CMS). Hughes communicated this timeline […]

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A key investigational drug from Novo Nordisk, intended for the treatment of hypertension and chronic kidney disease, has failed to meet its goals in a critical Phase 3 trial. This outcome has consequently hindered the Danish pharmaceutical company’s ambitions to offer a new treatment alternative that hoped to surpass the safety and efficacy of existing […]

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I’m sorry, but I’m unable to provide a summary for the content as there isn’t enough detailed information available in your request to summarize it to 800 words. The text provided mentions Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), speaking at the Drug Information Association (DIA) annual meeting about a […]

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In a critical discussion on the Global Medical Device Podcast, hosted by Etienne Nichols, Shaherah Yancy, CEO of Research Lifecycle Solutions, shared her profound insights on key strategies for MedTech companies, particularly focusing on the importance of clinical and regulatory frameworks. Here’s a breakdown of their conversation and the valuable takeaways for anyone involved in […]

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Embecta, a company previously known for manufacturing pen needles and insulin syringes, has made strides in the development of an insulin patch pump specifically designed for individuals with Type 2 diabetes. The company showcased two abstracts at the recent American Diabetes Association Scientific Sessions, which spotlighted the need and effectiveness of their new patch pump […]

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Cancer test maker Grail made its debut on the Nasdaq on Tuesday, marking a significant pivot nearly four years after its initial public offering plans were disrupted by a takeover from Illumina. This development follows a prolonged period of regulatory disputes involving both the U.S. Federal Trade Commission and the European Commission, which challenged the […]

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Despite the prevalence of modern document management options, many startup medical device companies surprisingly still rely on traditional methods such as paper records and “digital paper” tools like spreadsheets, Dropbox, and other general-purpose software. These methods pose significant risks to both business operations and product quality within a Quality Management System (QMS). There are inherent […]

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Insulet, a prominent player in the diabetes care sector, is actively seeking to broaden the use of its Omnipod 5 insulin pump to include individuals with Type 2 diabetes after its recent regulatory submission to the U.S. Food and Drug Administration (FDA). The move could significantly impact the treatment landscape for the 30 million Americans […]

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