FDA

The clearance applies for Sectra Digital Pathology Module, the key component of Sectra's pathology solution, when used together with Leica Biosystems' scanner AT2 DX. This enables US healthcare providers to use Sectra's digital pathology solution for primary diagnostics. The solution makes it possible to move towards fully integrated diagnostics, which is especially important in complex cancer cases.

As part of the Trump Administration's all-hands-on-deck approach across public, academic, and private sectors to combat the COVID-19 pandemic, the FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments.

The novel single-use micro-endoscope with multiple working channels eliminates the risk of transmitting infections between patients notes enlightenVue.

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic. Read on.

The FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S.

INVU is a prescription-initiated, protocol-driven remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless, self-administered INVU sensor band.

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the Coronavirus pandemic.

The U.S. Food and Drug Administration reports today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.