Pulsenmore Ltd., a healthcare technology company developing self-use ultrasound solutions for remote care, announced that it has completed the CE European registration process for Pulsenmore FC, its home ultrasound system for monitoring follicular development and endometrial thickness during IVF and fertility preservation treatments.
Completion of the registration process under the European Medical Device Regulation (MDR) marks an important milestone in Pulsenmore's strategy to expand its home ultrasound platform into additional applications across women's health. Having established its activities in prenatal monitoring, the Company is now extending its platform into fertility care, where repeated ultrasound examinations are a central component of treatment management.
According to data from the European Society of Human Reproduction and Embryology (ESHRE), more than 1.15 million assisted reproduction treatment cycles were reported across Europe in 2023. More than half of these involved treatments requiring ovarian stimulation, including IVF, ICSI and fertility preservation, where repeated ultrasound scans are used to monitor follicular development and help guide treatment decisions. This monitoring can require women to make frequent clinic visits, often within a relatively short period of time.
Pulsenmore FC is designed to enable part of this monitoring to take place in the patient's home. The system includes an ultrasound transducer for self-use and a dedicated application, aiming to enable women to perform scans at home with remote guidance from physicians or ultrasound professionals, as part of a care pathway managed by the fertility team. For patients, performing part of the ultrasound monitoring at home can reduce the need for repeated clinic visits and allow them to better maintain their work, family and daily routines during an intensive course of treatment, while performing a private examination in the privacy of their own home. For fertility clinics, shifting part of the monitoring outside the clinic may support more efficient use of clinical staff and examination rooms, reduce workload and free up capacity to care for additional patients.
In a clinical study conducted at Rabin Medical Center among women undergoing IVF or fertility preservation, a high level of agreement was demonstrated between home ultrasound scans and in-clinic ultrasound examinations. High levels of satisfaction were also reported among both patients and clinical staff. The study was published in the peer-reviewed Journal of Medical Internet Research (JMIR), which focuses on digital health.
In Israel, the system has received approval from the Ministry of Health. In January 2026, Pulsenmore signed a commercial agreement with Clalit Health Services to establish a service based on Pulsenmore FC through Clalit NEXT and Beilinson Medical Center. Registration of the system under the European MDR now enables the Company to market and sell Pulsenmore FC across European markets.
