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.