The warning letter urges users and providers to throw the entire test cartridges in the trash due to the increased risk of false results.

The company said that if a specific combination of factors comes together, there is a risk of thermal injury.

The family-owned business reinforces its commitment to quality and evolving regulatory requirements.

In part 3 of MD+DI’s interview with Jim O’Connell, he details the potential longevity for connected care in medtech, as well as the challenges it could face.

Trivia Tuesday: What medical device company became embroiled in a fight with FDA that ultimately led to disciplinary action against two agency employees and the unseating of two advisory panel members?

Here are the sessions that MD+DI editors are keeping their eyes on during MD&M South.