Salute e Benessere
Pulsenmore Receives FDA De Novo Marketing Authorization for Home-Use Prenatal Ultrasound, Pioneering a New Era of Prenatal Care in the U.S.
The Pulsenmore ES integrates at-home ultrasound imaging into physician-led prenatal care. The Pulsenmore cradle connects to the patient's smartphone and guides her step-by-step via the Pulsenmore app. Captured video clips are securely transmitted to physicians for review and interpretation on a dedicated dashboard. Pulsenmore's U.S. clinical validation was achieved through a multi-center trial conducted at four leading academic and clinical institutions.
By enabling home-based self-scanning with remote clinician review, Pulsenmore ES helps health systems expand access and improve continuity of care while maintaining medical supervision at the center of prenatal care. " ," added Dr. Wulf Utian , an acknowledged world expert in women's health. "By reducing unnecessary visits, easing maternal anxiety, and improving triage, Pulsenmore's innovation benefits patients, clinicians, and healthcare systems alike."
The Pulsenmore ES does not replace in-clinic diagnostic or anatomical ultrasound examinations, but . "With FDA marketing authorization, Pulsenmore introduces a transformative model for prenatal care-extending ultrasound access beyond the clinic and redefining how we reach and monitor expectant mothers," said Dr. Alfred Abuhamad , Chairman of Pulsenmore's Medical Advisory Board.
Pulsenmore's home ultrasound platform is already in use across health systems in Israel , Europe , Brazil , and Australia , supporting more than with remote clinical interpretation. The company partners with -one of the world's largest HMOs, and , consistently ranked among the top 10 hospitals worldwide. Pulsenmore is preparing for a in collaboration with leading clinical institutions in .
"Pulsenmore's solution bridges distance and capacity barriers, enabling physicians to stay connected to their patients throughout pregnancy," said . "Pulsenmore ES brings connected, clinician-led ultrasound directly into the home-making prenatal care more accessible and equitable."
Access to the device operation must be granted by prescribing Physicians.
(TASE: PULS) develops and commercializes home-use ultrasound solutions that securely connect patients and clinicians. Its mission is to make high-quality ultrasound accessible anytime, anywhere through self-scanning with clinical supervision.
Clinically validated and backed by large-scale commercial adoption, Pulsenmore's home ultrasound and telehealth platform supports hybrid prenatal care models across multiple global health systems.
For more information, visit www.pulsenmore.com
Vice President, Global Marketing, Pulsenmore Ltd.
Tel: +972-50-591-1212
Email: mira@pulsenmore.com
Photo - https://mma.prnewswire.com/media/2811690/Pulsenmore_ES.jpg
Video - https://www.youtube.com/watch?v=D1SyDqTvQxA
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