Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...

FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...

Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...

President Donald Trump has swiftly announced a series of executive orders that could impact the medech industry.

The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...

In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...

The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...