Medscape6d
FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
Becker's Hospital Review25d
FDA spotlights risks in medical device supply chain
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
Forbes11d
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...
aha.org4d
FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...
FierceBiotech26d
FDA's device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...
JD Supra28d
FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products
Steps 1 and 2 ... for devices with AI-enabled device software functions. This guidance fits within FDA’s Total Product Life Cycle (“TPLC”) approach to reviewing and monitoring medical ...
JD Supra29d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
(2) AI in medical devices; and (3) privacy considerations regarding the use of AI in clinical research. Potential Uses of AI in Clinical Trials In the JAMA article, FDA lists several areas of ...