Pulsenmore, a healthcare technology company developing self-use ultrasound solutions for remote care, announced that it has completed the registration of Pulsenmore FC with the MHRA, the UK regulatory authority responsible for medical devices. The registration enables the Company to market the system in the United Kingdom and Northern Ireland, and follows the recent completion of the system's European registration under the Medical Device Regulation (MDR).
Pulsenmore FC is a home ultrasound system for women undergoing IVF and fertility preservation treatments. The system enables patients to perform vaginal ultrasound scans themselves from home to monitor follicular development and endometrial thickness, with remote professional guidance, as part of a treatment pathway managed by the fertility care team. By moving part of ultrasound monitoring from the clinic to the home, the system can reduce the need for repeated clinic visits and allow patients to better integrate monitoring into their daily lives.
The UK represents a significant and growing market for fertility treatment. According to the Human Fertilisation and Embryology Authority (HFEA), the UK's independent regulator of fertility treatment, approximately 53,000 patients underwent IVF in 2024, with more than 100,000 fertility treatment and storage cycles performed at HFEA-licensed clinics. Around 21,400 babies were born through IVF in 2024, accounting for 3.2 per cent of all UK births.
Pulsenmore FC is Pulsenmore's second product to reach international markets, following the Company's home ultrasound system for pregnancy monitoring, and marks the Company's expansion from pregnancy monitoring into the broader women's health market.
Dr. Elazar Sonnenschein, Founder and CEO of Pulsenmore, said, "Following our recent European registration, our entry into the UK opens another significant market for Pulsenmore in fertility care. This is an important step toward turning the technology we have developed into a care model that can be implemented in fertility clinics across different markets. Fertility treatment currently requires patients to adapt a significant part of their daily lives around monitoring. We want to reverse that equation, enabling part of the monitoring process to fit into the patient's life, while keeping the clinical team at the center of care. We intend to expand the use of Pulsenmore FC into additional countries with a significant number of IVF and fertility preservation cycles."
