SyntheticMR receives FDA 510(k) clearance for SyMRI 15

SyntheticMR, leader in quantitative imaging software, is pleased to announce that its SyMRI 15 solution has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) on diagnostic image replacement of conventional images.

Sammanhang: ...SyntheticMR, leader in quantitative imaging software, is pleased to announce that its SyMRI 15 solution has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) on diagnostic image replacement of conventional images....

Hamlet BioPharma receives U.S. FDA Fast Track designation for Alpha 1H for the treatment of non-muscle invasive bladder cancer

Lund, Sweden, November 29, 2023. Hamlet BioPharma AB (publ), the pharmaceutical company with a strong portfolio of projects for the treatment of cancer and infections, announces today that the U.S. Food and Drug Administration (FDA) has granted Fast Track

Sammanhang: ...The U.S. FDA Fast Track Designation accelerates the approval process for Alpha 1H and potential for reaching the US market....

Omnämnda platser: Lund, Sweden. Omnämnda personer: Hamlet BioPharma, Hamlet BioPharma AB.