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.
Veeva has launched a new tool to help MedTech developers identify and engage with healthcare experts and key opinion leaders.
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
Connected sensors are a key component to improving patient access to and patient retention in clinical trials. Following are considerations for developers and sponsors when designing and selecting sensors for use in trials.
Including figures and images in clinical research enables researchers to illustrate their findings in a clear, effective and engaging way. Yet, it can be difficult to manually check images for accuracy, introducing the risk of integrity issues. Following we look at best practices and new tools developed to ensure image integrity in clinical research.
The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the reality that children cannot themselves consent to take part in research.
Improving clinical trial equity can help close the gap between the challenges to enroll and retain patients in clinical trials and the growing burden of diseases. All in all, there are immense benefits to creating and providing remote technologies for clinical trial participants.
Randomized clinical trials are the gold standard for conducting clinical research. They are, however, fraught with issues and come with burdens to the patient, site and sponsor. Decentralized trials (DCTs) allow for a novel, agile and more cost-effective approach to an industry standard and traditional methodology. Here’s how to determine if a full or hybrid DCT is a good option for your clinical trial.
“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.
