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App icon of Pulsenmore ES, from the App Store

Is Pulsenmore ES FDA approved or cleared?

Yes. Pulsenmore ES by Pulsenmore, Ltd. is named in the FDA register with a De Novo authorisation, latest decision in 2025.

In the EU: CE class IIa, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.

At a glance

Product	Pulsenmore ES
Maker	Pulsenmore, Ltd.
Care area	Women's health & fertility
What it does	Prescription handheld home ultrasound for singleton pregnancies at 14 to 38 weeks (BMI under 40); a physician interprets the images remotely to determine fetal heart rate. Not for detecting defects or replacing routine scans or emergency care
FDA	De Novo, latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	Class IIa
EU certificate	Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026)
Website	pulsenmore.com
Status	FDA verified
Last checked	7 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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