Covidien O2 saturation measurement devices win FDA's 510(k)

Covidien CEO José Almeida

Covidien ($COV) nailed down a 510(k) clearance, this time for a group of next-generation Nellcor pulse oximetry monitoring devices--a regulatory win that will likely help fuel continued robust growth in the line.

Oximetry devices measure arterial oxygen saturation, and the new clearance applies to Nellcor products including the Bedside SP02 Patient Monitoring System, the Bedside Respiratory Patient Monitoring System and the N-600x Pulse Oximetry Monitoring System. FDA clearance allows the devices' use as a motion-tolerant bedside treatment.

Pulse oximetry monitoring devices fit into a category of medical devices that amount to "bread and butter" revenue sources for medical device companies. They are staples in hospitals and rehab facilities, as well as for hospital transport and home use. But devices can become outdated, and a continued push to update and modernize will keep the segment competitive.

That's crucial, considering the segment is one of the healthiest at Covidien in terms of sales growth. Covidien, which is restructuring, said its oximetry and monitoring division booked $250 million in revenue during the fiscal 2015 second quarter. That is up an impressive 14% from the $220 million the company pulled in for the division during the same period last year.

- read the release

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