Pulsenmore Reports 374% Revenue Surge to $12.5M, Secures FDA De Novo and CE Approval
Pulsenmore reported 2025 revenue of $12.5 million, a 374% increase driven by a $9.6 million GE settlement, and narrowed net loss to $5 million from $10 million. It had $21.7 million in liquid assets at year-end 2025 and secured FDA De Novo plus CE approval for its home-use ultrasound.
1. Financial Highlights
Pulsenmore posted $12.5 million revenue in 2025, up 374% from $2.6 million in 2024; gross profit rose to $10.5 million (84% margin) from $0.98 million (37% margin), while net loss narrowed to $5 million from $10 million. Cash and equivalents plus short-term investments totaled $21.7 million at year-end.
2. GE Settlement Revenue
The company recognized approximately $9.6 million one-time revenue from a settlement and order cancellations with GE Precision Healthcare LLC, which resolved outstanding disputes and terminated the Component Agreement.
3. Regulatory Milestones
Pulsenmore obtained FDA De Novo authorization for remote-use prenatal ultrasound in the U.S. and CE certification under MDR for its Early-Screening pregnancy product, enabling single-fetus commercial distribution from 14 weeks gestation in the EU.
4. Commercial Outlook
Initial U.S. pilot programs have validated integration of Pulsenmore’s home-use ultrasound into clinical workflows; management plans to scale infrastructure, expand clinical partnerships, and drive recurring revenue streams to capitalize on the remote prenatal diagnostics market.