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The FDA should engage in global standards discussions.

The Importance of U.S. Involvement in Global Medical Standards When U.S. regulators are not part of the conversation while global medical standards are established, it carries significant risks for patient safety, medical innovation, and cybersecurity. This issue isn’t just a matter of regulations; it directly impacts the quality of healthcare we receive. Key Takeaways: U.S. …

Vinay Prasad’s Comeback and the Disruption of mRNA

Are Investors Losing Faith in mRNA Biotechs? Investors are always on the lookout for the next big thing in biotech, and mRNA technology has had its moment in the spotlight. However, recent trends suggest that enthusiasm may be waning. This week’s episode of “The Readout LOUD” dives into this topic and much more. Key Takeaways: …

Medicare ought to include FDA-approved drugs and medical devices in its coverage.

The Case for Medicare Covering FDA-Approved Medical Innovations In a recent interview, FDA Commissioner Marty Makary suggested a straightforward but impactful reform: Medicare should automatically cover devices labeled as breakthrough by the FDA. In a health care system bogged down by bureaucracy, this idea stands out as both sensible and necessary. Key Takeaways: Medicare needs …

Sensor-Based Digital Health Technology: Insights from FDA Authorizations (2015-2025)

I. Executive Summary The landscape of medical devices is undergoing a profound transformation, driven significantly by the emergence and rapid expansion of sensor-based digital health technology (sDHT). This report provides a comprehensive analysis of FDA authorizations for sDHT devices from 2015 to 2025, revealing a sector characterized by robust growth, strategic diversification, and a pronounced …

SSRIs, Pregnancy, and Depression: Key Insights from the FDA Panel

Understanding Mental Health During Pregnancy: Why Treatment Matters Navigating pregnancy can be a whirlwind of emotions. For some, it’s a time filled with joy and anticipation; for others, it’s a struggle with mental health challenges like anxiety and depression. This is a reality faced by many, including Tinelle Windham, who experienced intrusive thoughts and panic …

Artificial Intelligence (AI)

AI in Healthcare: Revolutionizing Patient Care and Diagnosis

TL;DR Summary Artificial Intelligence (AI) is fundamentally transforming healthcare by enhancing patient care and diagnosis. Key benefits include faster and more accurate diagnoses, personalized treatment plans, predictive analytics for better outcomes, and improved operational efficiency. Innovations such as AI-driven imaging, virtual health assistants, and personalized medicine are shaping the future of healthcare. Embracing these technologies …