Covidien patient monitoring system receives clearance

Covidien has received FDAO 510(k) clearance and CE Mark approval for its Nellcor bedside respiratory patient monitoring system.

The Dublin-based healthcare product manufacturer’s SpO2 monitoring system features alarm management tools and is designed to accommodate multiple settings with wireless connectivity for remote monitoring, according to an Oct. 4 statement.

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“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”