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NOWDx Submits De Novo Classification Request to the FDA for OTC Syphilis Test

NOWDiagnostics submitted a De Novo Classification Request to the U.S. FDA for the company’s First to Know at-home syphilis test.

Picodya, the creator of a hybrid IVD solution for multiplexed POC testing, announced the deployment of its B-Matrix technology in NIH labs.

Posted by Andy Lundin | Jan 5, 2024 | Lung Cancer |

The diagnostic, which requires only a simple urine test to read the results, could make lung cancer screening more accessible worldwide.

Sekisui formalized an exclusive distribution agreement with Aptitude Medical Systems to sell the Aptitude Metrix COVID Test in the U.S.

Daxor submitted its next-generation blood volume analyzer—Daxor BVA—to the U.S. FDA via the 510(k)/CLIA-waiver dual submission pathway.