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Fischer Medical gets FDA 510(k) clearance for cardiac stimulator device

Published 10 April 2018

Fischer Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for Bloom2 cardiac electrophysiology stimulator device.

The Bloom2 stimulator is a fundamental component of nearly all electrophysiology (EP) procedures to diagnose and treat cardiac rhythm disorders. 

The release of the digital version of the Bloom gives electrophysiologists and EP staff members a modern user interface, eliminates tedious dropdown menus and retains the tactile feel of the original Bloom.  Physicians have long used the original analog Bloom for their patients since it was introduced by Murray Bloom in the 1970s. 

The Bloom2 was painstakingly engineered with the classic Bloom user in mind, mapping the analog system directly to the digital so the adoption of the digital system would be simple and intuitive for Bloom customers.

Fischer Medical president and CEO Wes Rogers 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."

Fischer Medical is a leading medical device manufacturer located in Wheat Ridge, CO.  Fischer Medical is the successor company to Fischer Imaging Corporation, which was a leading manufacturer of medical imaging equipment in the United States. 

Fischer Imaging Co. pioneered stereotactic needle biopsy under digital mammography guidance and developed one of the first Full Field Digital Mammography (FFDM) systems. 

Fischer Imaging Co. sold over $1B in x-ray systems, with over $400M to OEM partners such as GE Healthcare , Varian, Dornier, Philips, Kodak and Storz.  In 1992, Fischer Imaging acquired Bloom Associates, Ltd. from Murray Bloom.

Source: Company Press Release