News We’re Watching: More Class I Recalls, FDA Expands TAP, Guardant Appeals Patent Verdict, And More

This week, the US FDA labelled several recalls class I, approved an at-home diagnostic for chlamydia and gonorrhea, and announced the expansion of its TAP pilot program. Guardant Health also announced it would appeal a verdict in a patent suit against the company and AdvaMed voiced its continued support for pending breakthrough device legislation.

Regulatory News We're Watching
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Cardinal Health initiated a recall in September of some Cardinal Health Monoject syringes because they differ from the previously branded Covidien Monoject devices and have different dimensions.

In total, the company recalled more than 32 million syringes which are used to inject fluid into the body or withdraw fluid. When used with syringe pumps, the Monoject disposable...

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