If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
4/14/2023
/ Artificial Intelligence ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Physicians ,
Preemption ,
Software ,
Standard of Care ,
Strict Product Liability
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more