Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 ...
Last week, the Food and Drug Administration (FDA) authorized the first at-home, OTC test to detect syphilis — a much-needed diagnostic tool for an infectious disease that has experienced a spike in ...
Credit: NOWDiagnostics. The at-home test can be used to inform individuals of current or past infections in 15 minutes using a single drop of blood. Confirmatory testing should be conducted by a ...
-MeMed BV Flex™ simultaneously measures multiple host proteins, paired with machine learning, to deliver highly accurate results in 15 minutes from just a few drops of blood- -Designed for use in ...
Erika is the CEO and Co-Founder of Sanguina, an Atlanta-based biotech company that provides digital health wellness & diagnostic screening. The healthcare landscape in the United States is ...
Confirmatory testing should be conducted by a health care provider as the test alone is not sufficient to diagnose syphilis infection. The Food and Drug Administration (FDA) has granted marketing ...