Pulsenmore Wins FDA Approval for Home Ultrasound Pregnancy Device
Israeli medical device company Pulsenmore has announced that the US Food and Drug Administration (FDA) has granted marketing approval for its home ultrasound device for pregnant women.
The company already markets its device in Israel through an agreement with Clalit Health Services and has been awaiting approval for the US market. Prior to trading, the company had a market cap of NIS 195 million.
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.
Statement by Elazar Sonnenschein.
Author's summary: Pulsenmore gets FDA nod for home ultrasound device.