Spanish medtech company Innitius has received CE marking for CerviSense, an intravaginal probe and software platform that measures cervical stiffness to support clinical decisions in preterm birth management and labor induction.
The certification enables commercial launch across Europe for the device, which provides operator-independent measurements of cervical tissue biomechanical properties. Clinical validation studies were conducted in Spain, the United Kingdom, and Germany prior to approval.
CerviSense integrates into existing clinical workflows to deliver reproducible measurements of cervical stiffness, a parameter used in assessing risk of preterm birth and determining readiness for labor induction. The technology aims to reduce variability in cervical assessments that currently depend on manual examination.
“This achievement marks a major step in our mission to bring better diagnostic tools to women’s health,” said Rubén Molina, CEO of Innitius. “We are now ready to bring CerviSense to market and expand access to a reliable, evidence-based assessment that has the potential to improve outcomes for mothers and babies.”
Clinical Applications and Technology
The device measures tissue elasticity to quantify cervical consistency, with AI-powered models integrating clinical data to provide real-time assessments for labor management decisions. This approach addresses limitations of current cervical assessment methods that rely on subjective manual examination.
Cervical consistency assessment plays a critical role in obstetric care, influencing decisions about preterm birth interventions and timing of labor induction. Current methods show significant inter-operator variability, which can affect clinical decision-making and patient outcomes.
Market Expansion and Funding
Innitius is advancing a multi-center clinical program to strengthen evidence and expand indications for the technology. The company is currently raising a Series A funding round to support regulatory approval processes and global commercialization efforts.
While CE marking enables European commercialization, the company is preparing regulatory submissions for other markets including the United States. The Bilbao-headquartered company has not disclosed specific timeline or investment targets for its Series A round.
