Pulsenmore, a healthcare technology company, has completed registration of Pulsenmore FC with the MHRA, the UK's medical device regulator. The move clears the home ultrasound system for sale across the UK and Northern Ireland, following its recent European registration under the Medical Device Regulation.

Pulsenmore FC is a patient-operated system that allows women undergoing IVF and fertility preservation treatment to perform vaginal ultrasound scans at home to monitor follicular development and endometrial thickness, with remote guidance from a healthcare professional as part of a fertility team's treatment pathway. The company reported full-year 2025 revenue of ₪40 million (€10.1 million), up 314 percent on the prior year, according to Simply Wall St.

The UK represents a substantial fertility treatment market. Approximately 53,000 patients underwent IVF in 2024, with more than 100,000 fertility treatment and storage cycles carried out at licensed clinics, according to the Human Fertilisation and Embryology Authority. Around 21,400 babies were born through IVF that year, accounting for 3.2 percent of all UK births.

"Following our recent European registration, our entry into the UK opens another significant market for Pulsenmore in fertility care," said Dr Elazar Sonnenschein, founder and chief executive of Pulsenmore. "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."

Pulsenmore FC is the company's second product to reach international markets, following its home ultrasound system for pregnancy monitoring, marking the company's expansion from pregnancy monitoring into the broader women's health market.

The structural driver behind the launch is growing regulatory acceptance of patient-operated diagnostic devices as a way to shift routine monitoring away from clinic capacity without removing clinical oversight from the treatment pathway.

For the sector, the UK registration confirms that home-based diagnostic devices are moving from pregnancy care into more clinically sensitive fertility monitoring, widening the addressable market for remote ultrasound technology.

Source: prnewswire.com / simplywall.st