In the evolving ecosystem of life sciences and healthcare delivery, digital health has emerged not only as a technological adjunct but as a core strategic pillar in drug commercialization and lifecycle management. For pharmaceutical manufacturers, the integration of digital health solutions is no longer a novelty or a differentiator. It is a requirement for delivering […]
Transferring your Swiss Authorized Representative (CH-REP) is a critical regulatory activity requiring meticulous planning, rigorous execution, and thorough knowledge of regulatory requirements. As Switzerland’s regulatory landscape closely mirrors the EU’s stringent standards, understanding these requirements in detail is vital for a successful transition. This blog post delves deeply into each step necessary for smoothly transferring […]
In October 2024, Tsinghua University’s Institute for Artificial Intelligence Industry Research in Shijiazhuang, Hebei Province, unveiled Agent AI Hospital, the first fully autonomous healthcare facility managed by AI agents. This virtual hospital deploys fourteen physician agents and four nursing agents to handle every step of patient care—triage, diagnostic testing, treatment planning, and follow-up—within simulated consultation […]
Introduction to healthcare AI lifecycle Artificial Intelligence (AI) is transforming healthcare at an unprecedented pace. From predictive analytics that forecast hospital readmissions to deep‑learning algorithms that detect abnormalities in radiology images, AI promises more accurate diagnoses, personalized treatments, and streamlined operations. Turning a healthcare AI concept into a reliable clinical asset requires a structured, repeatable […]
Aging, an inevitable biological process, has long been associated with a decline in physiological functions and an increased risk of chronic diseases. However, recent advancements in aging research and drug discovery are challenging this narrative, offering promising avenues to not only extend lifespan but, more importantly, healthspan—the period of life spent in good health. This […]
Healthcare technology has advanced by leaps and bounds, yet one timeless challenge remains: patients won’t benefit from innovations they don’t use. Even the most effective medical device or digital health app can fall short if patients aren’t engaged or motivated to use it consistently. Behavior change design is emerging as the key to bridging this […]
I have always believed that the real power of business lies in sustainable growth. This conviction has guided me through every partnership, project, and strategic decision I have made. As the CEO of Aura Health, a company that collaborates with pharmaceutical and life sciences organizations to develop and commercialize digital health solutions, I am keenly […]
Saray Ugidos Seman, Head of Clinical, Regulatory, and Quality Affairs at Aura Health, highlights the critical role of regulatory expertise in the early stages of medical device development. She underscores that startups, in particular, must prioritize regulatory knowledge to avoid costly setbacks and ensure a smoother path to market entry. Many emerging companies underestimate the […]
On January 7, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. This document consolidates and refines the agency’s existing recommendations for the content required in marketing applications for medical devices that incorporate AI-driven software functions. The goal is to […]
Artificial intelligence (AI) is rapidly transforming the landscape of drug development, offering innovative solutions to complex challenges in the pharmaceutical industry. Recognizing the profound impact of AI, the U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological […]
