FDA-Cleared Home Ultrasound Device Paves Plasanmor’s Entry Into the U.S. Market

Plasanmor shares soared on Sunday after the company announced a partnership with Ouma Health, a U.S. virtual care provider for pregnant women. Under the deal, Ouma will incorporate Plasanmor’s home ultrasound system into its pregnancy care offering, aiming to help women maintain continuous monitoring throughout pregnancy. Ouma operates in all 50 U.S. states through ties with major insurers, health systems, OB-GYN groups and community health centers, giving Plasanmor potential access nationwide.

Plasanmor did not disclose the financial terms of the agreement, but said the U.S. sees about 3.6 million births a year and that roughly 35% of counties are classified as obstetric care deserts, where pregnant women lack physical access to prenatal exams and treatment. Those areas are the main target market for the device. The company received U.S. FDA clearance in November to market the home ultrasound it developed.

The product lets pregnant women monitor the fetus themselves, using guidance from a mobile app and remote instruction from a medical professional. Plasanmor says this can reduce the number of in-person clinic visits and support proactive remote follow-up. The device is already sold in Israel through Clalit Health Services and, on a smaller scale, in Europe.

Plasanmor previously had a marketing agreement with General Electric for the U.S. and Japan. GE invested $21 million in June 2022, then canceled a further $21 million commitment in September 2023 and later scrapped an order to distribute 15,000 systems, citing technical problems integrating Plasanmor’s systems with Apple devices. The dispute ended in a settlement in August, under which GE lost its exclusive distribution rights in the U.S. and Japan but remains a nonexclusive distributor until June 2029. Plasanmor, controlled by CEO Dr. Elazar Sonnenshein, who holds 29% of the shares, went public in the 2021 IPO wave. After peaking at a 733 million shekel valuation, the stock had fallen 92% to 66 million shekels before the Ouma announcement. It then jumped 225.4% in Tel Aviv to a 214.5 million shekel market value, and the company also began trading on Nasdaq in January.