In this blog, we’ll explore what personalized medicine is, its significance in healthcare, and how the FDA regulates it to ensure safety and efficacy.
Results for "diagnostic technologies"
Harmonizing Health: The EU Framework for Regulating Combination Products
Within the European Union (EU), the regulation of combination medical device and drug products is meticulously governed by a comprehensive framework to ensure patient safety, efficacy, and regulatory compliance.
Revolutionizing Healthcare: AI/ML Advancements in the Medical Device Industry and FDA’s Regulatory Blueprint
In this blog, we will explore how AI/ML is revolutionizing the medical device industry and the FDA’s plans for regulating this dynamic space.
The FDA and AI/ML in Medical Devices: Navigating the Future of Healthcare
Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing healthcare, offering unprecedented opportunities to improve patient outcomes, streamline processes, and enhance diagnostic accuracy. As AI and ML continue to make significant strides in the medical field, the U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating these innovations. In this blog post, we’ll explore the intersection of AI/ML and medical devices, and how the FDA is navigating this rapidly evolving landscape.
Regulation of MedTech Products in India
Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.
The Importance of Women in MedTech
Since at least the early 1800s, women have played an integral part in advancing the MedTech industry along. Many...
Data Mining as A Service in Medical Devices
Data mining is the field of Computer Science that forms the basis for data analytics. As the term specifies, it is...
FDA’s Emergency Use Authorization
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is...
3D Printed Medical Devices
Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical...
The Opioid Epidemic, and the Role of Medical Technology
Overview The opioid epidemic can be traced back to the late 1990s, when the medical community began to prescribe...
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