The MosaiQ AiPlex CD is designed to improve the  accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows EYSINS, Switzerland , Feb.

Collaboration to provide Firefly with the technical resources to help further unleash the power of its FDA-cleared BNA™ platform For the ...

“This is another key milestone as we expand our reach to the UK following successful approval across Europe for our innovative infertility and cancer detection products.” stated Kathy Lee-Sepsick, ...

Sometimes people get a permanent tattoo then later decide they no longer want it. Life situations change or maybe the tattoo ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA has issued warning ...

A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...

vaccine has recently been submitted for clinical trials to the U.S. Food and Drug Administration (FDA). The vaccine has demonstrated significantly higher humoral and cellular immunity compared to ...

The recent FDA clearance marks not only an important step toward the realization of a potentially game-changing tool, it also shows that a once-doubted machine-learning technique used to create ...