Innitius

Company overview

Innitius is a medical device company based in Derio, Bizkaia, Spain, founded in 2017 and led by CEO and co-founder Rubén Molina. Its CerviSense platform measures cervical tissue stiffness to add quantitative biomechanical information to obstetric assessment.

The handheld intravaginal probe uses torsional wave elastography to produce a numerical stiffness measurement. Innitius is developing condition-specific AI models that combine cervical measurements with clinical information for spontaneous preterm labor screening, threatened preterm labor triage and induction-of-labor assessment. The measurement hardware is CE-marked, while these predictive applications remain in clinical validation.

CerviSense is listed in GE HealthCare’s Voluson Solution Store as a standalone system for cervical elasticity assessment. The company’s clinical programme spans European hospitals, with ongoing studies in threatened and spontaneous preterm labor and additional induction research in preparation. Earlier research used the Fine Birth device name, which also remains the name of its EU-funded FineBirth development project.

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Products & regulatory status How does MedTechIndex get this information?

Summary

CerviSense’s cervical-stiffness measurement hardware is CE-marked. The European Innovation Council dates European hardware certification to 2025, and GE HealthCare lists the device in its Voluson Solution Store. CerviSense is a standalone system; the listing does not mean it is built into a Voluson scanner. ^[9][7][8]

The condition-specific AI models for spontaneous preterm labor screening, threatened preterm labor triage and induction assessment remain in clinical validation. Innitius distinguishes the CE-marked measurement device from these predictive applications. The EIC timeline identifies European certification of the threatened-preterm-labor indication as a planned 2027 milestone. ^[4][9]

A 2026 multicenter study of 305 symptomatic pregnancies found moderate discrimination from cervical stiffness alone and stronger discrimination when stiffness was combined with cervical length. The authors described stiffness as complementary information and called for further development of multivariable prediction models. ^[11]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-11-03.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Cervical stiffness measurement system

CerviSense ↗

Standalone intravaginal probe that uses torsional wave elastography to measure cervical stiffness. The CE-marked hardware supports quantitative tissue assessment; associated AI models for preterm labor risk and induction assessment are undergoing clinical validation. ^{[3][4][8][9][11]}

CE-marked hardware · Predictive applications in clinical validation