Fischer Medical wins FDA 510(k) for Bloom2 cardiac stim

Fischer Medical said today it won FDA 510(k) clearance for its Bloom2 cardiac electrophysiology stimulator device designed to aid in the diagnosis and treatment of cardiac rhythm disorders.

The newly launched Bloom2 is a digital version of the company’s Bloom device and features a modern, improved user interface while maintaining the tactile feel of the original Bloom device.

The Bloom2 system was designed to match the earlier Bloom device in terms of usability to make adoption of the system easier for existing Bloom customers, the Wheat Ridge, Colo.-based company said.

“The Bloom2 represents years of research and development to integrate the key components of what made the original Bloom the market leading stimulator worldwide. The Bloom2 is the only stimulator on the market that offers the tactile feel of the original Bloom combined with a state-of-the-art user interface,” prez & CEO Wes Rogers said in a prepared statement.

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