Regulatory Affairs, SaMD & Digital Health Expert
Key Takeaways: The approval of a groundbreaking gene therapy for Duchenne muscular dystrophy faced unexpected setbacks. FDA safety concerns led to the immediate halting of treatment deliveries. Families awaiting treatment are left in limbo, dealing with emotional turmoil and uncertainty. Communication from manufacturers and regulators is crucial in managing the anxiety of affected families. In …
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 …
TL;DR: The future of healthcare is telemedicine, and it’s changing the way patients receive care. From virtual consultations to remote monitoring, telemedicine is revolutionizing the healthcare industry by making access to medical services easier and more efficient. With the rapid evolution of technology, patients can expect more convenient and personalized care in the years to …
TL;DR: Evaluating the Effectiveness of Software as Medical Device in Clinical Settings examines how software is transforming healthcare and the challenges and benefits it brings. From improving patient care to data security concerns, this article delves into the complexities of this innovative technology. Hey there, friend! Let’s talk about how software is revolutionizing the world …
TL;DR: Regulatory affairs for biotech startups can be challenging due to complex regulations, but provide opportunities for growth and innovation. By understanding the regulatory landscape and being proactive in compliance, startups can set themselves up for success in the industry. So, you’re thinking about launching a biotech startup? That’s awesome! The field of biotechnology is …