Pulsenmore ES Device, Efficacy and Safety Assessment

A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women

This is a multicenter, prospective, investigational device study designed to evaluate:

The safety, feasibility, and accuracy of the device, when used by pregnant individuals

Inclusion Criteria:

• Singleton gestation.
• Gestational age >14 weeks with a prior scan demonstrating fetal viability and confirming dates.
• English or Spanish speaking.
• Ability to understand and sign the informed consent (available in English and Spanish).
• Ability to read and understand instructions that are required for equipment use (instructions available in both languages).

Exclusion Criteria:

• Multiple gestations.
• BMI >40.
• Known fetal and genetic anomalies.
• Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash).
• Subjects allergic to the ultrasound probe materials.
• Non-English/ non-Spanish speaking.
• Unable to provide consent.