Hologic wins U.S., Canada & European approval for OG-BYN scope
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The Omni hysteroscope is now available in Canada, Europe and the U.S.
Marlborough medical device maker Hologic has been granted approval from three geographic markets since December for a three-in-one hysteroscope.
The approvals began in December with U.S. Food & Drug Administration approval. On Monday, the company said it was granted a medical device license from Health Canada and a CE mark for European approval.
The Omni hysteroscope is equipped with advanced visualization capabilities for both diagnostic and therapeutic procedures.
Surgeons are often forced to use a diagnostic scope to look in the uterine cavity for abnormalities and then switch to an operative scope to biopsy or treat the pathology. With the new Omni scope, doctors can use the same scope with different attachments to do both with the same tool.
According to the company’s financial reporting from 2018, the U.S. makes up about 75 percent of its revenues, while Europe comes in at just under 12 percent. Canada is not listed on the report.
According to Hologic’s website, it operates one location in Canada in Toronto.
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