FDA approval

In a ‘First,’ Perimeter’s Claire AI‑Enabled Imaging Device for Breast Cancer Surgery Gains FDA Approval

by | Mar 4, 2026
Designated by the FDA as a Breakthrough Device, Claire is designed to enhance surgeons' ability to detect difficult-to-see cancer during breast-conserving surgery and potentially reduce the need for re-operations.
MORE
Alpha Cognition Inks $44M Deal With China’s CMS to License Alzheimer’s Drug in Asia and Beyond
by | Jan 9, 2025
Alpha Cognition’s Alzheimer’s oral therapy ZUNVEYL, FDA-approved in July, targets U.S. launch in Q1 2025 as the company boosts its commercialization team with five new hires.
MORE
North Texas’ Caris Life Sciences Gets FDA Approval for its ‘MI Cancer Seek’ Companion Diagnostic Test
by | Nov 6, 2024
Caris said MI Cancer Seek will be used as a companion diagnostic to identify cancer patients who may benefit from treatment with targeted therapies.
MORE
Alpha Cognition’s ZUNVEYL Receives FDA Approval to Treat Alzheimer’s Disease
by | Jul 29, 2024
“The approval of ZUNVEYL is a pivotal moment in the fight against Alzheimer's disease as it's only the second oral AD treatment to be approved in more than a decade," said CEO Michael McFadden of Alpha Cognition. Based in Vancouver with an office in Frisco, the company was honored at the 2023 BioNTX iC3 Summit as one of eight "Rising Stars."
MORE