Poster Session 4
Category: Digital Health Technologies (DHT)
Poster Session 4
Ronit Shtrichman, MBA, PhD (she/her/hers)
Clinical Director
Pulsenmore
Boston, Massachusetts, United States
Erkan Kalafat, MD, MSc
Associate Professor
Koc University Hospital, Istanbul
Koc University Hospital, Istanbul, Istanbul, Turkey
Lawrence D. Platt, MD
Professor of OB/GYN; Director, Center for Fetal Medicine and Women's Ultrasound
UCLA David Geffen School of Medicine and Cedars-Sinai Medical Center
Los Angeles, California, United States
Sara Little, MD
Maternal-Fetal Medicine, Beth Israel Deaconess Medical Center
4. Maternal-Fetal Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Paola Aghajanian, MD
UCLA David Geffen School of Medicine, Cedars-Sinai Medical Center
UCLA David Geffen School of Medicine, Cedars-Sinai Medical Center, California, United States
Shirley Platt, MD
UCLA David Geffen School of Medicine, Cedars-Sinai Medical Center
UCLA David Geffen School of Medicine, Cedars-Sinai Medical Center, California, United States
Kris Ann Tychon
Department of Maternal Fetal Medicine, Brigham and Women’s Hospital, Boston
5. Department of Maternal Fetal Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, United States
Nicola F. Tavella, CPH, MPH (he/him/his)
Clinical Research Program Director
Division of Maternal-Fetal Medicine, Icahn School of Medicine, Icahn School of Medicine at Mount Sinai Hospital
New York, New York, United States
Angela T. Bianco, MD
Professor and Division Director, Maternal-Fetal Medicine
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Telehealth is reshaping prenatal care by improving patient satisfaction, reducing costs, while maintaining safe clinical outcomes. Pulsenmore is a handheld ultrasound device connected to a smartphone via a mobile app, enabling pregnant women to perform scans at home (Figure 1). Scans are securely interpreted by clinicians, supporting a hybrid care model.
Study Design:
This prospective, multicenter study evaluated the safety and efficacy of the Pulsenmore self-operated ultrasound platform. Pregnant women (≥14 weeks) were enrolled across four U.S. centers and completed three weekly sessions. Scan types included: App-Guided (AG) – self performed at home via video tutorial, Clinician-Guided (CG) – home scan during a telehealth visit, and In-Clinic (IC) – standard ultrasound serving as ground truth. AG and CG scans were reviewed by 10 experts assessing image quality (ACEP grading), fetal cardiac activity (FCA), amniotic fluid volume (AFV), fetal movement, breathing, and placental location. Safety and ease of use were also evaluated.
Results:
A total of 1370 scans (458 AG, 453 CG, 458 IC) from 162 pregnancies were analyzed. No device- or procedure-related serious adverse events occurred. FCA was diagnosed in 98.5% (CG) and 95.2% (AG) of scans by ≥ 8 readers, with excellent inter-reader reliability (Gwet’s AC2: 0.805 CG, 0.846 AG). FCA assessment success rate exceeded 95% across all visits (Figure 2). Sensitivity analyses showed no significant impact of gestational ages, BMI, or education levels on FCA assessment (p > 0.05). AFV, placental location, fetal movement and breathing (GW >27) assessments were comparable between Pulsenmore and IC scans. 83% of patients reported a positive experience; 93% found the device easy to use.
Conclusion:
Pulsenmore demonstrates strong clinical evidence for safety, efficacy and usability in home-based fetal well-being monitoring.