Day: November 2, 2023

A recent publication of a placebo-controlled clinical trial in China with a Traditional Chinese Medicine (TCM) product showed signification benefits in the management of Acute ST-segment elevation myocardial infarction (STEMI). However, what would be the likelihood of FDA acceptance of clinical data from such a study to support its approval as a conventional drug? 0 … Read more

With a wide-ranging and far-reaching Executive Order signed this week by President Biden, the administration is implementing several requirements from developers of products containing Artificial Intelligence (AI) technologies that would affect digital health products, somewhat. The order is primarily focused on the safety and privacy of the information used to train AI algorithms but also … Read more