FDA – Sixapart

The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin...

5 steps to navigate the FDA’s new lab developed test rule

November 6, 2024 admin

Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies...

Updated COVID shots from Pfizer, Moderna cleared by FDA

August 28, 2024 admin

The reformulated messenger RNA vaccines are designed to more closely match currently circulating coronavirus variants. Article By: Ned Pagliarulo Blog...

FDA panel recommends new standards for pulse oximeters amid bias concerns

February 19, 2024 admin

Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care. Article...