CooperSurgical Confirms Continued FDA 510(k) Clearance for Fetal Pillow^® cephalic elevation device

TRUMBULL, CT — CooperSurgical confirms that Fetal Pillow^® cephalic elevation device maintains, without interruption, an FDA 510(k) clearance. An updated review and clearance was issued in August of 2025. This decision was based on the FDA’s review of the complete body of clinical evidence supporting the device’s UNCHANGED performance, safety profile, and intended use.

Fetal Pillow is indicated to elevate the fetal head and facilitate delivery of the fetus in women requiring cesarean section at full dilation or after failed instrumental vaginal delivery at ≥37 weeks’ gestation. By providing controlled elevation of the fetal head from the vaginal route, the device is designed to help reduce technical complexities of other methods during second stage cesarean delivery, an intervention associated with increased maternal and fetal morbidities and mortalities.

Since its initial FDA clearance in 2017, Fetal Pillow has remained the only FDA-cleared device specifically indicated for fetal head elevation during second stage cesarean section. The updated 2025 review reaffirmed that the totality of available clinical evidence supports the device’s safety and effectiveness.

Fetal Pillow is in routine clinical use across more than 2,500 birthing hospitals globally, including major U.S. health systems. To date, over 220,000 units have been sold worldwide. Across these implementations, the device has demonstrated ease of integration into existing labor and delivery workflows and when used as directed, Fetal Pillow has a strong safety record across thousands of cases globally.

We prioritize patient safety and support HCPs in anticipating the unexpected. There are more than 40 peer reviewed articles that continue to demonstrate consistent clinical utility. For access to the full clinical evidence summary or to discuss the underlying data in detail, please contact your CooperSurgical Sales Representative, who can connect you with our Medical Affairs team.

About CooperSurgical

CooperSurgical is a leading company dedicated to advancing the health of women, babies, and families. The company’s portfolio offers effective solutions that support clinical efficiency from conception to delivery. With a history of innovation in the fertility and women’s health field, CooperSurgical has pioneered new technologies and continues to drive progress in the industry.

Media Contact:
CooperSurgical
[email protected]