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    Impact of Innovative Healthcare Technologies: Regulatory Concerns of Ambulatory Cardiac Monitoring Devices

    This article provides an insight into the various types of Cardiac Monitoring Devices (CMD) available and their usefulness in remote cardiac monitoring for the early detection and treatment of arrhythmias. The article focuses on the technological innovations incorporated into these devices and the impact of this technology on the healthcare industry, regulatory challenges associated with their clinical utilization and potential solutions to those challenges.   Introduct...
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    Cybersecurity Susceptibilities in Networked Medical Devices

    This article discusses how the US medical device industry is facing cybersecurity risks due to their wireless connectivity over the internet. It provides a brief overview of the common types of cyberthreats and the medical devices affected and describes the regulations in place to oversee this issue. Introduction Over the previous decade, there has been an enormous explosion of minute networked medical gadgets supporting an assortment of health maladies, right from the ...
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    Regulatory Challenges in Mobile Medical Applications

    This article presents the challenges associated with the regulation of mobile medical applications compared to computer software. The authors identify the differences between mobile applications and computer systems to determine the practical challenges of regulating these mobile applications as Software as a Medical Device (SaMD). This article also highlights various principles that can be followed to ensure patient safety and wellness by mobile application manufacturers...
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    Overcoming the Challenges in Getting Cancer Vaccines to Market

    This article discusses advances in the development of “personalized” cancer vaccines and reviews the many challenges that need to be overcome to get new cancer vaccines approved and on the market. The authors highlight FDA’s “Regenerative Medicine Advanced Therapy” (RMAT), a comprehensive policy framework aimed at providing oversight for cancer vaccines and regenerative medicine products, including novel cellular therapies. Introduction Cancer continues to be one of the...
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    Master Protocol and Combination Products Development: A Step Closer to Precision Medicine

    This article discusses the challenges and benefits related to using the “master protocol” and “platform” study design in conducting clinical trials of combination products, trials where the product is comprised of two or more regulated components. The authors speculate on regulatory challenges arising from employing alternative clinical trial procedures and processes and examine changes in FDA policy regarding clinical trials with combination products. Introduction Comb...