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Nanoleaf is jumping into beauty tech with a $150 face mask
Specifically, a $149.99 LED face mask. The Nanoleaf LED Light Therapy Face Mask is made of medical-grade materials and has received FDA Class II device certification. (This doesn’t mean the FDA ...
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 Review26d
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.
Forbes12d
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 ...
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FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products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 ...