Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the ...

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid ...

SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons ...

Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of ...

Natalie Holt sees reminders nearly everywhere of the serious toll a years-long syphilis outbreak has taken in South Dakota ... and tribal groups need to "divide and conquer" as they work to test and ...

Syphilis is simple to treat – if caught early. If not, however, the health consequences can be very serious.

If your rapid COVID-19 tests have reached their expiration dates, don't toss them just yet. Here's how to find out if their ...

At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy ... the FDA has also cleared a CLDN18.2 diagnostic test from Roche that can be used to test if patients ...

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca's top-selling respiratory drug Symbicort, although launch plans remain ...

Caris said MI Cancer Seek will be used as a companion diagnostic to identify cancer patients who may benefit from treatment ...

In February 2024, the U.S. FDA approved Aurlumyn (iloprost), an injectable vasodilator treatment that is the first ever to be approved for the treatment of severe frostbite. This approval was ...