IdentifySensors Biologics, a leading developer of digital diagnostic technologies, has initiated the FDA review process by submitting a pre-EUA for emergency use authorization of a rapid Ebola ...

The FDA announced a new fast-track approval program for domestic drug developers for projects that are national priorities.

The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices. In a remarkable pilot, ELSA has proven to significantly reduce the time ...

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR. On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and ...

Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback. Nexalin Technology, Inc. Thu, May 1, 2025, 10:30 AM 2 min read.

CLEVELAND, May 20, 2025 /PRNewswire/ -- IdentifySensors Biologics, a leading developer of digital diagnostic technologies, has initiated the FDA review process by submitting a pre-EUA for ...

Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback Provided by GlobeNewswire May 1, 2025, 2:30:00 PM. HOUSTON, TX, ...