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Pulsenmore Gains European Approval for Home IVF Monitoring System

Pulsenmore has secured CE registration under European medical device regulations for its home ultrasound system, marking the company’s expansion from prenatal care into the fertility market. The device allows patients undergoing IVF to track follicular development and endometrial thickness remotely, reducing the need for frequent clinic visits.

Pulsenmore Gains European Approval for Home IVF Monitoring System
Photo: Bio & News

The Pulsenmore FC system combines a portable ultrasound transducer with a dedicated mobile application, enabling patients to conduct scans from home under professional guidance. By shifting routine monitoring out of the clinic, the technology aims to ease the logistical burden on patients while freeing up capacity at fertility centers. According to the European Society of Human Reproduction and Embryology, over 1.15 million assisted reproduction cycles occur annually across Europe, with the majority requiring intensive ovarian stimulation and repeated imaging.

A clinical study at the Rabin Medical Center, published in the Journal of Medical Internet Research, validated the system by demonstrating high agreement between home-performed scans and traditional in-clinic examinations. Following successful implementation in Israel, including a partnership with Clalit Health Services, the new regulatory clearance allows Pulsenmore to begin commercializing the device across European markets. CEO Dr. Elazar Sonnenschein noted that this milestone transitions the company from a single-product provider to a broader platform for women's health technology.

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