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NewsNewsPulsenmore has completed MHRA registration of Pulsenmore FC, entering the UK fertility market with its patient-operated home ultrasound system for follicular and endometrial monitoring during IVF and fertility preservation treatments. The move follows CE European registration and targets a UK market where over 100,000 fertility treatment cycles were performed in 2024.
Pulsenmore, a healthcare technology company developing self-use ultrasound solutions for remote care, has announced the completion of 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 across the United Kingdom and Northern Ireland and follows the recent completion of the system's European registration under the Medical Device Regulation (MDR).
The Pulsenmore FC UK fertility market entry marks a significant step in the company's commercial expansion, opening access to one of Europe's most established fertility treatment ecosystems. 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 during the same period. Around 21,400 babies were born through IVF in 2024, accounting for 3.2% of all UK births, figures that together underline the scale and clinical significance of the market Pulsenmore is now entering.
Pulsenmore FC is a home ultrasound system built specifically for women undergoing IVF and fertility preservation treatments. The system enables patients to perform vaginal ultrasound scans themselves from home, monitoring follicular development and endometrial thickness under remote professional guidance, as part of a treatment pathway managed by the fertility care team. By moving part of the ultrasound monitoring process from the clinic to the home, Pulsenmore FC is designed to reduce the number of repeated clinic visits that fertility patients are currently required to make and to allow patients to better integrate monitoring into their daily lives, without removing the clinical team from the centre of their care.
Pulsenmore FC is Pulsenmore's second product to reach international markets, following the company's home ultrasound system for pregnancy monitoring. Its registration in the UK marks the company's expansion beyond pregnancy care into the broader women's health market, a strategic move that extends the platform Pulsenmore has built in remote ultrasound into a new and sizeable clinical application.
Dr. Elazar Sonnenschein, Founder and CEO of Pulsenmore, spoke directly to the reasoning behind the UK entry and the company's broader ambitions for the system:
"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."
The ambition Dr. Sonnenschein describes reflects a tension that sits at the heart of fertility treatment as it is currently structured: the monitoring demands of a standard IVF cycle and repeated early-morning clinic visits for blood tests and ultrasounds across multiple weeks place a significant logistical and personal burden on patients, many of whom are simultaneously managing work, family, and the emotional weight of treatment itself. Pulsenmore FC is designed to shift part of that burden, enabling the monitoring process to follow the patient rather than requiring the patient to follow the clinic.
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