CrossBay Medical has obtained the US Food and Drug Administration (FDA) clearance for its product, the SonoSure Sonohysterography and Endometrial Sampling Device, indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.

The device has also received Health Canada clearance and the CE mark.

Saline Infusion Sonohysterography (SIS) and Endometrial Biopsy (EMB) are routinely used in the workup for Abnormal Uterine Bleeding (AUB), which occurs in 20% of women between the ages of 19 to 55.

Currently, these procedures are performed in a single setting using separate instrumentation for each procedure or providers may require patients to have separate visits for the procedures.

The SonoSure device combines Saline Infusion Sonohysterography and Endometrial Biopsy in the same device.

CrossBay Medical CEO Piush Vidyarthi said the company is excited about receiving the clearance for SonoSure as it can now provide its affiliate partners in the US, Canada and Europe with a truly affordable and effective product.

"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," Vidyarthi added.

Additionally, the company has entered into an exclusive distribution agreement to commercialize the product.

Image: SonoSure SonoHysterography and Endometrial Sampling Device gets FDA, Health Canada, and CE mark marketing authorizations. Photo courtesy of CrossBay Medical, Inc./ PRNewswire