Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...more
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
During the 2020 COVID-19 pandemic, statistics have shown a significant decline in emergency room and hospital admissions for multiple conditions, including acute coronary syndrome (ACS) (-40–50%), stroke (-30–40%), and cancer...more
On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more
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