The committee will advise the Commissioner of Food and Drugs on issues related to Digital Health Technologies (DHTs), and FDA policies and regulations about these technologies, providing relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks and clinical outcomes associated with use of DHTs.
For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.
Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.
This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.
The blueprint includes opportunities for various healthcare stakeholders to contribute to the full optimization of digitally enabled care and includes case examples featuring organizations with care models that leverage the blueprint’s six pillars.
Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space.
The second part of this two-article series on digital therapeutics (DTx) sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success.
There is significant opportunity to develop therapies that create new standards of care and initiate a new wave of precision medicine.
Unauthorized access could allow an attacker to take full control of the host operating system.
Fueled by the need to provide quality care during a global pandemic, healthcare stakeholders are acting quickly to identify new opportunities and overcome challenges.