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Showing posts from April, 2025

Real-World Imaging Datasets to Enhance Precision Medicine

Healthcare delivery is evolving from population medicine to precision medicine. Precision medicine means customizing the treatment to a subpopulation that differs in disease susceptibility, process, progression, or response to a medication. Based on factors such as genetics, lifestyle, environment, etc., the treatment is tailored to the individual. The main aim is to provide the right medicine for the right individual. This ensures that individuals get medications that work best for them, i.e., better efficacy and fewer side effects. How precision medicine is being practiced currently At present, precision medicine is mainly driven by genomic data, electronic health records (EHRs), and biomarkers. By analyzing and integrating these datasets, researchers identify patterns and correlations in the disease processes and treatment response. Advancements in big data and AI/ML enable for analysis of vast amounts of datasets, to obtain targeted therapies. How real-world data (RWD) is helping d...

From Concept to Clinical Practice: How Segmed Powered RadUnity’s Fast-Track to FDA Clearance

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Customer: RadUnity Corp. Industry: Medical Imaging / HealthTech Founder: Tim “Stick” Szczykutowicz, Ph.D. Product: A harmonization platform for CT imaging data tailored for radiologists, researchers, and AI applications The Challenge As RadUnity set out to build its Minimum Viable Product (MVP), a critical barrier stood in the way: access to a sufficiently diverse and representative dataset of CT scans. Their vision—to standardize harmonized imaging as a core utility within medical institutions—relied heavily on validating their platform with images from various manufacturers, sites, and patient demographics. Manually sourcing this data would require RadUnity to negotiate with individual healthcare providers, navigate complex legal agreements, and invest significant time and resources into data aggregation. For a startup pushing toward FDA clearance and early clinical adoption, this was not just a bottleneck—it was a potential deal-breaker. The Segmed Solution Segmed provided RadUnity ...

Unlocking the Power of Real-World Imaging Datasets in Post-Market Surveillance

As drugs and medical devices continue to evolve and develop, post-market surveillance (PMS) has been a critical activity deemed necessary and regulated by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) to assess the long-term safety and efficacy of the medical product. Post-market surveillance refers to the monitoring of medical products (therapies and devices) safety and efficacy, following the market release of the product, by collecting information from healthcare professionals, patients, and regulatory bodies. It helps identify adverse events, determine efficacy patterns, and assess long-term effects, which subsequently helps inform risk assessment, regulatory response, and labeling modifications or further research. However, challenges related to optimizing post-market surveillance and obtaining new information on clinical efficacy and long-term assessment still exist. To tackle this, real-world data (RWD) has become indispensable, offering greater in...

Unlocking the Power of Real-World Imaging Datasets in R&D - Clinical Trials

Discover how real-world imaging datasets transform clinical trials, enhancing insights, efficiency, and decision-making. Introduction Clinical trials are the reference standard for generating evidence that validates the safety and efficacy of new treatments, devices, or therapies. They provide the definitive proof required for regulatory approval, ensuring an intervention is both effective and safe before it reaches the target population. However, the economics behind these trials are complex, with costs often exceeding hundreds of millions of dollars due to rigorous protocols, lengthy timelines, and high regulatory demands. Despite these investments, trials have a chance of failing, resulting in losses and delays in bringing the treatment to the population.  Utilizing real-world data (RWD) for this process can address the challenges of clinical trials, offering insights that can improve efficiency and reduce cost. RWD helps ensure the identification of the right population for re...

Alzheimer's Disease: Power of Real-World Imaging Data (RWiD)

Discover how Real-world imaging datasets are revolutionizing Alzheimer's research by providing unique and comprehensive perspectives and insights Introduction Alzheimer's disease (AD) is a progressive neurodegenerative disorder affecting millions worldwide. Alzheimer’s disease is the most common cause of dementia and is expected to affect 150+ million people by 2050. Despite decades of research, effective treatments remain limited, with no cure available for the disease. There are also gaps in understanding the disease’s progression, which continue to hinder advancements. Alzheimer’s is caused by complex pathophysiological changes, marked by the accumulation of amyloid plaques and tau proteins in the brain. This leads to gradual neuronal damage and atrophy of brain tissue. Despite decades of research and being a major public health problem, the understanding of exact mechanisms remains poor. The multidimensional pathophysiology and the diverse presentations of the disease furth...