RedDrop Dx CEO and co-founder Kris Buchanan said: “Receiving FDA Class II medical device clearance for RedDrop One, our industry-leading solution, allows us to play a crucial role in improving ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

While the brand originally initiated the recall in December, the FDA just recently classified the recall as a Class II, meaning “a situation in which use of, or exposure to, a violative product ...

The US Food and Drug Administration has approved the use of a novel painkiller as an effective treatment for short-term ...

Most manufacturers of Class I and Class II medical devices seek to avoid the FDA’s premarket approval (PMA) pathway at all costs, opting instead for the kinder, gentler, and faster 510(k) route. But ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

Here are three recent recalls reported to the FDA: ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect ...