Pulsenmore’s at-home ultrasound platform, Pulsenmore ES, has received de novo authorisation from the US Food and Drug Administration (FDA).
Pulsenmore ES enables pregnant women to perform guided scans at home that are subsequently interpreted by remote physicians, helping to streamline obstetric care and address growing obstetric care access constraints in the US.
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After the authorisation was granted, Pulsenmore’s stock, listed on the Tel Aviv stock market, rose 32.75% on 2 November, from NIS377.40 ($115.77) at market close on 30 October to a NIS501.00 at market close on 2 November.
Research from 2024, published in BMC Pregnancy and Childbirth, found that inequities in obstetric care access affect more than two million women in the US who live in maternity care ‘deserts’. According to the research, the scarcity of care access, which is most prevalent in rural regions, heightens the risks of pregnancy-related complications.
Pulsenmore ES comprises a cradle into which users insert their smartphone while a remote physician provides step-by-step guidance to capture a successful ultrasound scan via the system’s companion app. Once completed, the scans are securely transmitted to physicians for review and interpretation on a dedicated dashboard.
The de novo authorisation was granted following the completion of a multi-centre clinical validation trial (NCT05329077) to affirm Pulsenmore ES’s safety and efficacy at a total of four medical centres and academic institutions across the US.
With de novo authorisation in hand, the company is now preparing for a phased US launch of its platform in collaboration with leading clinical institutions in Q1 2026.
Pulsenmore’s CEO and founder Dr Elazar Sonnenschein said: “Pulsenmore’s solution bridges distance and capacity barriers, enabling physicians to stay connected to their patients throughout pregnancy.
“Pulsenmore ES brings connected, clinician-led ultrasound directly into the home-making prenatal care more accessible and equitable.”
Already in use across health systems in regions, including Europe, Brazil, and Australia, Pulsenmore’s de novo authorisation and imminent US market rollout is due in part to a $50m strategic investment GE HealthCare made in the Israeli start-up in 2022 to help it access the US home ultrasound market.
Pulsenmore ES is part of the telehealth devices and broader patient monitoring markets. According to GlobalData analysis, the markets are forecast to reach valuations of around £210m and $24.9bn by 2034, respectively.
