CrossBay Medical has obtained US Food and Drug Administration (FDA) clearance for its SonoSure Sonohysterography and Endometrial Sampling Device, for use to access the uterine cavity for saline infusion sonohysterography and obtain endometrial biopsy, if indicated, using the same device.
The device has also received Health Canada clearance and the CE Mark.
The SonoSure device treats abnormal uterine bleeding, which occurs in 20% of women aged 19 to 55. Saline infusion sonohysterography and endometrial biopsy are routinely used in the workup for the bleeding.
Many providers perform these procedures at the same setting, using separate instruments for each procedure, which requires cervix cannulation, or insertion of a tube, at least twice. Other providers may require patients to have separate visits for the procedures.
SonoSure combines Saline Infusion Sonohysterography and Endometrial Biopsy in the same device.
CrossBay Medical CEO Piush Vidyarthi said: "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."
In the US, CrossBay Medical also announced that it has entered into an agreement with Norgenix, which will have exclusive rights to market and distribute the device in the country.
Norgenix COO and senior vice-president Michael Rackley said at Norgenix, it is company’s goal to offer quality products that provide solutions to the unmet needs within women’s health.
"We immediately recognised the value that CrossBay Medical’s devices may have for Gynecology," Rackley said. "With the exclusive rights to market, sell, and distribute the SonoSure in the US, we look forward to providing such innovations to the healthcare marketplace."
Image: CrossBay Medical’s SonoSure tool for evaluating abnormal uterine bleeding. Photo: courtesy of CrossBay Medical, Inc / PRNewswire.