Utepreva Secures FDA Clearance for Advanced Endometrial Sampler

New York, USA – April 22, 2026

Utepreva announced the launch of its FDA 510(k)-cleared Endometrial Sampler, an innovative diagnostic device designed to enhance early detection of endometrial cancer through improved tissue and fluid collection. The next-generation device integrates multiple sampling mechanisms into a single procedure, enabling clinicians to obtain higher-quality specimens and accelerate diagnostic accuracy, particularly in early-stage disease where survival rates can reach up to 95%.

Advanced Sampling Technology Improves Diagnostic Accuracy

The Utepreva Endometrial Sampler introduces a novel multi-mechanism design, combining gentle tissue disruption, controlled suction, and sponge-based absorption to maximize tissue yield during a single sampling pass. This approach addresses limitations of traditional devices that rely on a single sampling mechanism, often resulting in insufficient specimen collection and the need for repeat procedures.

Preclinical testing demonstrated that the device achieved statistically significant improvements in tissue capture and uniform sampling, ensuring that clinicians can obtain comprehensive and diagnostically relevant samples. The collected material supports cytologic, histopathologic, and molecular analyses, enabling a more complete evaluation of potential malignancies from a single procedure.

This advancement is particularly critical in the early detection of endometrial cancer, where timely diagnosis significantly improves patient outcomes and reduces the need for invasive interventions.

Enhancing Patient Comfort and Clinical Efficiency

The device has been engineered with a strong focus on patient comfort, procedural safety, and clinical efficiency. Its slim-profile design minimizes discomfort, while an integrated cervical guard prevents over-insertion, reducing the risk of complications. Additionally, the soft sponge tip enhances tissue absorption while minimizing trauma, making the procedure safer and more tolerable for patients.

The sampling procedure can be completed in approximately 20 seconds in an outpatient setting, eliminating the need for dilation, sedation, or operating room resources. This enables healthcare providers to perform rapid, minimally invasive diagnostic evaluations, improving workflow efficiency and expanding access to early cancer screening.

By simplifying the diagnostic process, the device supports broader adoption of routine uterine evaluation, particularly for patients presenting with abnormal or postmenopausal bleeding or elevated cancer risk factors.

Transforming Early Detection in Women’s Health

Endometrial cancer is the most common gynecologic malignancy in the United States, with over 68,000 new cases diagnosed annually, and rising incidence rates. Early detection is critical, as survival outcomes decline dramatically in advanced stages, highlighting the need for reliable, noninvasive diagnostic tools.

The Utepreva Endometrial Sampler has the potential to transform the diagnostic pathway, enabling earlier identification of pre-cancerous and cancerous conditions. Its design supports integration into routine gynecologic care, similar to widely adopted screening tools such as Pap smears, paving the way for population-level screening strategies in uterine cancer detection.

The device is expected to be available to healthcare providers in October 2026, with planned presentations at major clinical conferences to support adoption and awareness. As healthcare systems increasingly prioritize early detection and minimally invasive diagnostics, innovations like this device are poised to play a critical role in improving outcomes and reducing healthcare burden in women’s health.

Source: Utepreva press release