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News 3

[US, FDA] FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes

Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that au..

미국 FDA 2024.09.06

[US, FDA] From Awareness to Action: Tackling the Rising Burden of Common Chronic Diseases

Since graduating from medical school in 1978, I’ve seen medicine and healthcare change in unimaginable ways for the better. However, one of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of common chronic diseases (CCDs), combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How..

미국 FDA 2024.07.26

[US, FDA] CDRH Issues Guiding Principles for Transparency of Machine Learning-Enabled Medical Devices

As artificial intelligence continues to evolve, we are seeing revolutionary opportunities to enhance health care, especially through machine learning. AI can be applied across the spectrum of health applications, including for the prevention, diagnosis, and treatment of a variety of medical conditions, as well as for a range of administrative tasks. Health products, including those that are medi..

미국 FDA 2024.06.21
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