Yes, the device is reliable and was tested, validated and approved for use in the US, Europe, Australia, Brazil, Switzerland, the UK, Colombia and Israel. Over 200,000 successful scans have been performed since the launch of the technology. These numbers demonstrate that women can confidently scan themselves, as the diagnoisis it self is being done by a trained clinical team. The remote clinical team can accurately identify parameters related to fetal vitality, such as fetal heartbeat, fetal movements, and amniotic fluid volume, based on these scans.
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RAMAT GAN, Israel, Nov. 3, 2025 /PRNewswire/ -- Pulsenmore Ltd. (TASE: PULS), a pioneer in home ultrasound solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted
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This approach could thus contribute to a more sustainable, resource- efficient, and barrier-free (in terms of access to healthcare) model of prenatal care, especially in regions with limited resources.
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We're excited to announce our new partnership with Cetina sp. z o.o., a leading provider of advanced medical technology in Poland.
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A heartfelt thank you to Univen Healthcare for hosting Pulsenmore at your fantastic booth during this year’s
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FAQ
Patient Frequently asked question
Is the device reliable? How can I scan myself if I’m not a professional sonographer or obstetrician?
How do I know if my smartphone is supported?
The Pulsenmore solution utilizes your smartphone’s processing and video streaming capabilities, communication protocols, display, and power resources. For this reason, not all smartphones meet the compatibility requirements. To insure your smartphone is compatible with the Pulsenmore Home Ultrasound check the Specification webpage.
Why is the device single-paitent use?
Our commitment to patient safety and reliable scans guides the device’s design and functionality. The Pulsenmore device, connecting to a patient’s personal smartphone, optimally utilizes smartphone capabilities, minimizing material and resource consumption for enhanced environmental sustainability.
1. The Pulsenmore self-scan device is designed for use within a specific timeframe and usage limit. Extending its lifetime may compromise reading integrity due to material limitations.
2. Responsibility for device maintenance and home storage after the initial period cannot be assumed, impacting transducer quality and ultrasound scan reliability.
3. The device design and validated cleaning protocol do not allow transfer between patients, to avoid cross contamination and infection.
Can the product be used in a pregnancy with multiple fetuses?
No, the product is subject to use in single pregnancies only.
Can the device increase anxiety or create dependency?
The home ultrasound device is designed to provide continuity during pregnancy care and is intended to give you peace of mind.
Can I scan without medical interpretation?
Every scan requires medical interpretation, and it’s important to wait until the files are fully uploaded. You are not expected to understand or interpret the ultrasound scans; just follow the app’s instructions to scan, and receive a response from skilled ultrasound professionals .