FDA granted Pulsenmore's De Novo request for the Pulsenmore ES on October 31. The grant creates a new device type: an ultrasound imaging system for acquiring images at home by lay users. It is DEN240074, product code SGJ, under a new regulation at 21 CFR 892.1590. FDA received the request on December 11, 2024, a 324-day review.
The ES is a smartphone cradle that lets a pregnant woman scan herself at home while a clinician reads the images remotely. Pulsenmore says the device has supported more than 200,000 scans in Israel, Europe, Brazil and Australia. Clalit Health Services, Israel's largest HMO, ordered 25,000 units in October 2024. The US validation study ran at four academic centers.
The company was founded in 2014 by CEO Elazar Sonnenschein and listed on the Tel Aviv Stock Exchange in 2021. Shares rose 33% on the news, to a market value near NIS 233 million, about $61 million. A phased US launch with clinical institutions is planned for early 2026.
A De Novo that writes the regulation for lay-user ultrasound also writes the predicate for everyone who follows. The special controls in 892.1590 are now the checklist for the next home ultrasound 510(k).