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Medical Devices / Submissions and Approvals

FDA Green Lights Biotronik’s Tachycardia Devices

March 19, 2019

Biotronik received FDA clearance for its Acticor and Rivacor high-voltage cardiac rhythm management devices.

The devices, used to treat patients with cardiac arrhythmias, have a smooth and elliptical shape to lessen skin pressure, reduce risk of skin erosion and provide patients greater comfort.

The products use Biotronik’s home monitoring system, allowing physicians to review a patient’s status remotely.  The devices are battery-powered, making them independent of the AC power supply.

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