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Medical Devices / Submissions and Approvals

Fischer Medical’s Cardiac Simulator Gains Clearance

April 10, 2018

Fischer Medical’s Bloom2 cardiac electrophysiology stimulator received 510(k) clearance from the FDA.

The device is modeled after the company’s original Bloom device but features a modern user interface that does away with dropdown menus.

The Bloom2 is used in electrophysiology procedures to treat and diagnose cardiac rhythm disorders, and is designed to have the feel of the original Bloom stimulator that was introduced in the 1970s.

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