CrossGlide ETS enables medical providers to conduct an office-based endometrial biopsy procedure without a tenaculum
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration.)
Health technology company CrossBay Medical has secured approval from the US Food and Drug Administration (FDA) for its CrossGlide ETS endometrial tissue sampler.
The new endometrial tissue sampler is said to be the third product to apply the frictionless CrossGlide technology platform.
CrossGlide ETS allows medical providers to conduct an office-based endometrial biopsy procedure in an efficient manner and without a tenaculum.
The company has designed the CrossGlide ETS to facilitate simple access to the uterine cavity compared to currently available modalities.
Endometrial biopsy is a common tissue-sampling procedure conducted in women’s health offices
Endometrial biopsy is a common tissue-sampling procedure conducted in women’s health offices across the world.
The CrossGlide device helps to avoid grasping and manipulation of the cervix to support dependable access into the uterine cavity irrespective of the complexity or variability of the patient’s specific anatomy.
According to the company, around four million endometrial biopsies conducted per year in the European Union and the US for gynecological indications, while an additional two million endometrial biopsies conducted for infertility reasons across the globe.
The company also intends to develop products for other office-based gynecology procedures using CrossGlid wherever cervical access is needed, including products for IUD insertion and hysteroscopy.
CrossBay Medical CEO Piush Vidyarthi said: “Uterine access in the office doesn’t need to be difficult and painful for the patients.
“It is tremendously rewarding to be able to make CrossGlide ETS available to US clinicians and their patients, and further our mission to address the all-too-common discomfort associated with biopsy performed in the diagnostic work-up of abnormal uterine bleeding disorders and infertility.”
In November 2019, Hologic launched Definity cervical dilator, to advance gynaecological procedures.
The company has designed the new cervical dilator in partnership with CrossBay Medical, to facilitate effortless access of uterine cavities.