FDA grants PMA nod to Medtronic for Real-Time Revel insulin mgmt system

The FDA this month granted premarket approval to Medtronic (NYSE:MDT) for its Paradigm Real-time Revel system designed to monitor glucose levels and manage insulin.

Medtronic did not release any information on its plans to launch the device in the U.S. post-approval.

The system is composed of both a Paradigm Real-time Revel insulin pump, Enlite glucose sensor and MiniLink transmitter, according to a release from the FDA.

Earlier this month, Medtronic said it tapped Henry Schein (NSDQ:HSIC) to be its exclusive distributor for some Type II diabetes products in the U.S.

Fridley, Minn.-based Medtronic said the Henry Schein Medical business will distribute the products to primary care physicians here, including its iPro2 Professional continuous glucose monitor and the i-Port Advance injection port.

In late November Medtronic launched a new “Pattern Snapshot” report for the iPro2 Professional CGM that’s designed to give healthcare providers a 1-page overview of a patient’s glucose data trends.

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