Regulatory Affairs, SaMD & Digital Health Expert
I like to write about people, the places they live and the things with which they choose to surround themselves. Here are some of my favorite pieces that made it into Article.
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: …
The Urgent Need for Including Pregnant Women in Drug Research Pregnancy is a unique time in a woman’s life, filled with excitement but also uncertainty, especially when it comes to taking medications. It’s essential to address the significant gaps in drug safety research for pregnant women. Here’s what you need to know. Key Takeaways Pregnant …
Key Takeaways FDA leaders are actively working to restore normal operations after recent disruptions. Employees have expressed concerns over staffing, funding for research, and the shift in meeting protocols. The FDA is committed to retaining staff and filling vacant positions while encouraging employee feedback. Navigating Change at the FDA: What’s Happening Inside? The FDA is …
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 …
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 …
Is Flouride in Our Water a Health Concern or Medical Freedom? Robert F. Kennedy Jr. has stirred considerable debate by advocating for the removal of fluoride from drinking water, framing it as a matter of personal choice and medical freedom. This issue has significant implications for parents, health professionals, and local communities. Key Takeaways: Kennedy …
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 …
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 …
TL;DR: Electronic Health Records (EHR) have been surrounded by myths and misconceptions, but it’s time to set the record straight. Let’s debunk some common myths and show how EHR can actually benefit both patients and healthcare providers. — Electronic Health Records (EHR) have been a hot topic in the healthcare industry for quite some time. …
TL;DR: Wearable technology is revolutionizing the fashion industry by merging style with functionality. From smart watches to biometric clothing, tech-infused fashion is changing the way we dress and interact with the world around us. Do you remember when wearable technology used to consist of clunky, unfashionable gadgets that screamed “nerd” more than “trendsetter”? Well, those …