Regulatory Nods for Combined SonoHysterography and Endometrial Sampling Device

CrossBay Medical, Inc., has announced a bevvy of regulatory authorizations. The company’s SonoSure™ Sonohysterography and Endometrial Sampling Device now has U.S.FDA and Health Canada clearance as well as CE mark approval.

Background

Abnormal Uterine Bleeding (AUB) occurs in 20 percent of women between the ages of 19 to 55. Saline Infusion Sonohysterography (SIS) and Endometrial Biopsy (EMB) are routinely used in AUB treatment. While many providers perform these procedures at the same setting, using separate instrumentation for each procedure requires cannulation of the cervix at least twice. Other providers may require patients to have separate visits for the procedures.

In contrast, the SonoSure™ device combines Saline Infusion Sonohysterography and Endometrial Biopsy in the same device, being indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if required.

In the US, CrossBay has entered into an exclusive agreement to commercialize the product in a distribution deal with Norgenix.

Company comments

“We are excited about receiving the clearance for SonoSure™ as we can now provide our affiliate partners in the US, Canada and Europe with a truly affordable and effective product,” said Piush Vidyarthi, CEO of CrossBay Medical Inc. “CrossBay’s goal is to continue to develop innovative devices for women and children for the global market. We have numerous products in development that we plan to bring to market in the near future.”

Source: CrossBay Medical, Inc., PR Newswire

 

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