Stereotaxis Inc. (STXS) announced that it has received regulatory approval of its Niobe remote magnetic technology for cardiac ablations in Japan. The company said that the approval allows it to begin marketing efforts, including establishing a local business infrastructure with in-country distributors, while working on obtaining reimbursement approval for full market entry, or the ability to initiate sales. Reimbursement approval is expected by the end of 2013.
Approval by the Pharmaceuticals and Medical Devices Agency, Japan's equivalent to the U.S. Food and Drug Administration, follows a successful three-year clinical trial of the Niobe system at the Tokyo Women's Medical University.
The cCompany looks forward to showcasing its Niobe technology for prospective Japanese clients at the annual Heart Rhythm Society (HRS) scientific session in May and the Japanese HRS meeting in July.
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