Israeli medical device company Pulsenmore (TASE: PULS), which has developed an ultrasound device for home use by pregnant women, has announced that the US Food and Drug Administration (FDA) has granted the company marketing approval for the device. The company already markets its device in Israel through an agreement with Clalit Health Services and has long awaited approval for the huge US market.
Pulsenmore’s share price rose 33% on trading on the Tel Aviv Stock Exchange (TASE) today. Before trading began today the company had a market cap of NIS 195 million.
Pulsenmore CEO Dr. Elazar Sonnenschein said, ‘Our device has been approved in the 510k de novo pathway. This means that there is no precedent for such a product in the US, and anyone who wants to enter the category now will have to compare themselves to a control group similar to the one we were asked to compare our treatment to.
"It is important to stress that the FDA's labeling for the product explicitly states that it is intended for home use, both with remote professional guidance - but also with digital guidance by the patient herself, without a professional. This is the first time such approval has been received for an ultrasound device."
In the past, the company signed a strategic marketing agreement with medical device giant GE, but this agreement was terminated, among other things, when Pulsenmore was unable to obtain FDA approval as quickly as it had hoped.
Sonnenschein previously explained that Pulsenmore planned and began implementing the trial during the Coviod pandemic, when it was very easy to recruit patients for remote medicine. With the end of the pandemic, the pace of testing slowed down. The company is now preparing to market its product independently, although it is not ruling out an agreement with distributors of different sizes, and is even in several talks with such companies, says Sonnenschein.
Published by Globes, Israel business news - en.globes.co.il - on November 2, 2025.
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