We are thrilled to share some exciting news!
Pulsenmore has been granted FDA De Novo Marketing Authorization for our Pulsenmore ES home ultrasound system in the United States.
This milestone marks the conclusion of a complex regulatory journey. Out of thousands of FDA clearances granted each year, only a few dozen devices receive De Novo authorization – and just a handful combine medical device with digital health innovation.
It’s a powerful validation of our innovation, scientific precision, and commitment to clinical safety and efficacy. We’re incredibly proud of our talented team whose dedication made this achievement possible.
Our technology will help bridge critical gaps in obstetric care in the U.S., empowering physicians to extend care with greater flexibility and supporting hybrid prenatal pathways that improve access, continuity, and equity of care.
Thank you for your continued trust and support in Pulsenmore – exciting times ahead!
Looking forward to seeing you in our upcoming events,
Warm regards,
The Pulsenmore Team
