CerviSense
CerviSense, from the Spanish company Innitius, is an intravaginal probe and software platform for hospital obstetric teams. It measures cervical consistency using patented torsional waves, and a proprietary AI algorithm combines that reading with the patient's history to assess risk.
What is CerviSense?
CerviSense is a medical device from Innitius, whose legal name is ULTRASOUND INNOVATION MEDTECH, S.L.: an intravaginal probe paired with a software platform. Its physical principle is the torsional wave, an elastic shear wave that travels through soft tissue in a coiled geometry, radially and in depth. Innitius contrasts these waves with conventional ultrasound, arguing that they are markedly more sensitive to changes in tissue consistency and therefore better suited to characterising the mechanical properties of an organ such as the cervix. In practice they allow the cervical shear modulus to be measured, a biomechanical marker that shifts as labour approaches.
A proprietary transducer captures what the company calls the biomechanical signature of the cervix. A proprietary AI algorithm then combines that parameter with the patient's clinical data to deliver a clear, actionable risk assessment. A single probe serves three clinical applications, each carried by its own model: early detection of spontaneous preterm birth around week 20, triage of threatened preterm labour between weeks 24 and 37, and assessment of cervical ripeness before induction of labour from week 37. The central argument is blunt: obstetricians have always felt cervical consistency with their fingers, and for the first time it can be measured, compared and tracked objectively across patients and across visits.
Three pillars are claimed: hardware precision, standardised acquisition (the same result whatever the operator, with automatic data transfer) and quantified consistency, with a touchscreen guiding the clinician step by step. The product page displays a CE-certified badge, IEC 60601-1 electrical safety, ISO 10993 biocompatibility, validated comfort and usability, and 91% reproducibility between users. Four clinical studies are listed: FB-CT2, the pivotal trial in threatened preterm labour (Spain and Germany, 457 patients, ongoing); QEPS in spontaneous preterm birth (United Kingdom, 1,000 patients, ongoing); MATERN-AID on induction (Sweden, 500 patients, in preparation); and Project HOPE (Senegal, Cameroon, Nigeria and the Democratic Republic of the Congo, in preparation). The device appears in the scientific literature under the name Fine Birth. Alongside it, a Research App moves probe data automatically into a database and the Science Research Platform aims to build the largest cervical consistency database in the world. Use is hospital-based and reserved to healthcare professionals.
What it does
- Measure the consistency, or softness, of the cervix objectively
- Quantify the cervical shear modulus, a biomechanical marker that changes as labour approaches
- Return a risk assessment by combining that measurement with the patient's medical history through a proprietary AI algorithm
- Triage threatened preterm labour between weeks 24 and 37
- Detect the risk of spontaneous preterm birth early, from around week 20
- Assess cervical ripeness before induction of labour, from week 37 onwards
- Transfer probe data automatically into a research database, with no manual step
When to use CerviSense / When not to
A quick filter to help you decide if CerviSense is the right fit.
When to use CerviSense
- Obstetricians and gynaecologists working in delivery suites and antenatal clinics, who gain a figure for cervical consistency that can be compared from one visit to the next instead of a judgement made with the fingers
- Midwives and obstetric triage staff, for whom the device is presented as an alternative to the manual vaginal examination when sorting women who present with suspected preterm labour
- Clinical research teams in obstetrics: the device sits at the centre of four studies, from the pivotal FB-CT2 trial in Spain and Germany (457 patients) to QEPS in the United Kingdom (1,000 patients), MATERN-AID in Sweden (500 patients) and Project HOPE in Senegal, Cameroon, Nigeria and the Democratic Republic of the Congo
- University and hospital researchers, whom the Science Research Platform invites to contribute to what Innitius describes as the world's largest cervical consistency database
- Quality and improvement leads in a maternity unit, given the publisher's claim that 85% of admissions following a threatened preterm labour turn out to be false positives
When not to use CerviSense
- Members of the public: this is a medical device handled by a healthcare professional, not a consumer product
- Pregnant women acting on their own behalf, since there is no mobile application and nothing can be bought online
- Clinical questions outside obstetrics, or outside the gestational windows covered (around week 20, weeks 24 to 37, and week 37 onwards): the underlying torsional-wave research extends to other soft tissues, but CerviSense addresses the cervix alone
- Teams looking for a software integration: no API is claimed, no third-party integration is named and no public technical documentation exists
- Buyers who expect to find a price online: there is no pricing page and no self-service purchase of any kind
How to use CerviSense
A typical end-to-end flow, from setup to results.
- Note first that there is no online sign-up and no self-service purchase: every call to action on the site is an invitation to make contact, such as 'Discover CerviSense', 'Let's talk' or 'Get in touch'
- Fill in the contact form, which asks for first and last name, email, company or hospital, role, type of organisation (University, Company, Hospital, Research group, Private or Other), country and a message
- Consent to the privacy policy, which the form requires before it can be submitted
- Wait for Innitius to reply; the commercial discussion and any deployment inside the institution are arranged from there
- In use, apply the intravaginal probe to the cervix during the examination
- The proprietary transducer emits the torsional waves and captures the response of the cervical tissue
- Follow the touchscreen, which guides the clinician step by step so the technique remains the same whatever the operator
- Data is transferred automatically and continuously, with no manual intervention
- The AI model matching the indication (spontaneous preterm birth, threatened preterm labour or induction of labour) is applied and returns the risk assessment
- Research users reach the Research App through the 'Login' area, at science.innitius.com; access is reserved, the public page returning only a shell with no visible form. The app was built for the King's College clinical trial that started in early 2025
Pros & Cons
Pros
- Replaces a subjective appreciation, the digital examination and the Bishop score, with a figure that can be compared from one visit to the next
- The result is presented as independent of the operator, with reproducibility announced at 91% between users
- A single probe covers three distinct clinical situations rather than one
- Hardware conformity is displayed on the product page: CE-certified badge, IEC 60601-1 electrical safety, ISO 10993 biocompatibility, and validated comfort and usability
- The clinical programme is substantial and transparent: four studies with their countries, sample sizes and status, backed by a library of scientific publications reaching back to 2015 and accessible from the site
- CT1 has been completed, exceeding its sensitivity (70%) and specificity (90%) targets, which the publisher positions above cervical length measurement and biomarkers
- The publisher is European, headquartered in Spain, and claims GDPR compliance while naming the applicable Spanish and European texts
Cons
- No price is public: there is no pricing page, no plan and no online quotation, so every enquiry goes through a sales conversation
- Two of the three indications rest on studies that are still ongoing or in preparation (QEPS ongoing, MATERN-AID and Project HOPE in preparation)
- The footer of every page warns that some products or features described are under development, not CE marked or FDA cleared and not intended for clinical use, which sits beside a CE-certified badge on the product page
- No API, no named third-party integration and no public technical documentation: how the device fits into a hospital information system is not documented
- The privacy policy covers the website only and says nothing about the processing of the patient data collected by the device; the paragraph listing recipients has been left as an unfilled template placeholder
- No hosting information, no data processing agreement, no list of processors and no information-security certification such as ISO 27001 or SOC 2
- No interface language is announced, there is no mobile application, and the site publishes no company incorporation date
Pricing & Plans
No pricing is published. The page sitemap lists only six URLs and none of them is a pricing page; no free plan, no free trial, no tier, no amount and no currency appear anywhere on the site. The stated commercial route is a contact request, the calls to action being invitations to talk, which is the usual arrangement for a hospital medical device.
Data, GDPR & hosting
A consolidated view of how CerviSense handles your data.
GDPR overview
Compliance is claimed explicitly and the applicable texts are named: Regulation (EU) 2016/679, Spanish Organic Law 3/2018 (LOPD-GDD), Royal Decree 1720/2007 and Law 34/2002 (LSSI-CE). The privacy policy restates the seven Article 5 principles, records a register of processing activities kept except under the Article 30(5) exemption, and names consent as the legal basis, withdrawable as easily as it is given. The supervisory authority is named, the Agencia Espanola de Proteccion de Datos, and the minimum age to consent is 14, with parental authorisation below that. An SSL certificate is cited as a security measure. The gaps are equally clear: no DPO, no data processing agreement, no list of processors, and a scope limited to the website rather than the device. No Article 27 representative is named, and none is required for an EU-established company. Both legal documents were updated on 9 January 2026.
Who owns the data?
Innitius, legally ULTRASOUND INNOVATION MEDTECH, S.L. (NIF B19654326, Camino Astondo Bidea 612, Derio, Bizkaia), is the data controller, represented by Ruben Castilla Gallego. The published documents cover the website only; they never address the patient data captured by the device. Processing rests on consent, withdrawable at any time, and covers identifying data and Article 9 special categories, health, genetic and biometric data, requiring explicit consent. Declared purposes are handling the enquiry and the resulting relationship, plus personalisation, operations and statistics, storage and marketing studies. The recipients paragraph is an unfilled template placeholder, so the site does not say who receives the data. Innitius separately claims ownership of all intellectual property in the site itself.
Reuse rights
There is no account, no user-generated content and no service terms of use, so the site grants the end user no reuse rights of its own. The opposite is stated explicitly: reproduction, distribution and public communication of the site's content for commercial purposes are forbidden without written authorisation, under Spanish intellectual property law. The only documented reuse mechanism is the GDPR right to data portability, listed alongside access, rectification, erasure, restriction, objection and the right not to be subject to automated decision-making. Exercising those rights requires a written request carrying a copy of an identity document, the grounds, a notification address, the date and a signature, sent by post to Camino Astondo Bidea 612, 48160 Derio (Bizkaia) or by email to info@innitius.com. Nothing is said about a using institution exporting the clinical data produced by the device.
Data retention & training
Hosting summary
The site publishes no hosting information at all: no country, no region, no provider and no data centre. No information-security certification is claimed either. The standards cited, ISO 10993 and IEC 60601-1 on the product page and ISO 13485 in a company news article, concern the device and the quality system, not where data is kept. The only technical measure named in the privacy policy is an SSL certificate, presented as guaranteeing encrypted transmission. The legal framework is clearer than the technical one: Spanish law applies, the courts of Bilbao (Bizkaia) are designated, and the supervisory authority is the Agencia Espanola de Proteccion de Datos. On international transfers, the policy declares none in progress and undertakes only to inform the user should data ever be transferred to a third country or an international organisation. One observation made outside the site, which must not be read as a statement by the publisher: the domain's IP address, 35.214.227.8, geolocates to the Netherlands on Google LLC's network. That is where the marketing website is served, and it says nothing about where clinical data would reside.
Things to keep in mind
Risks and trade-offs to weigh before adopting CerviSense.
- Automation bias: a numerical result can attract more confidence than it deserves and lead a clinician to give less weight to the physical examination and to their own judgement
- The strength of the evidence is not the same across indications: two of the three rest on studies still ongoing or in preparation, so a figure returned for one clinical question is not backed like a figure returned for another
- An internal contradiction to resolve before purchase: the product page shows a CE-certified badge while the footer on every page warns that some products or features described are under development, not CE marked or FDA cleared, and not intended for clinical use
- Health data is at stake, in the sense of Article 9 of the GDPR, yet the published policy covers the website alone; the processing of the patient data captured by the device is not documented publicly, and the paragraph naming the recipients of data was left as an unfilled template
- No hosting and no subprocessor information: the jurisdiction in which data would be stored is unknown to the reader
- An algorithm trained on given populations may generalise poorly elsewhere: the current studies run in Spain, Germany, the United Kingdom and Sweden, while those planned in West and Central Africa have not begun
- No incorporation date is published on the site and no beneficial owner can be identified from public sources, so supplier due diligence has to be carried out offline
Setup & Integrations
Technical difficulty
There is no software for the end user to install: this is a medical device delivered and deployed inside a healthcare institution. There is no self-service, no online sign-up and no API key: the way in is a contact form. In use, the publisher stresses simplicity: a touchscreen guides the clinician step by step, the technique is identical whatever the operator, and data transfers automatically. A reserved Research App exists at science.innitius.com. The real difficulty is institutional rather than technical: hospital procurement, staff training and regulatory approval. Innitius has published a guide to instrumentation acquisition criteria for hospital teams.
Deployment
Behind CerviSense
Fundraising
Social
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
What is CerviSense?
What technology is it based on?
Which clinical situations does it address?
Who is it for?
What does it add compared with a digital examination or a cervical length measurement?
Is the device certified?
How much does it cost?
Is there an API or any integration?
Where is the data hosted, and what does the privacy policy cover?
Where does clinical validation stand?
Should you pick CerviSense?
CerviSense is a tightly focused product: an obstetric medical device, not general-purpose software. Its promise is to replace a judgement made with the fingers, unchanged for a century, with an objective measurement, and to turn that measurement into a risk assessment through an AI model matched to the clinical question.
The evidence on display is serious: hardware standards (CE-certified badge, IEC 60601-1, ISO 10993), reproducibility announced at 91% between users, four clinical studies with their countries, sample sizes and status published, and a library of scientific publications going back to 2015. Maturity is nonetheless uneven from one indication to the next: the pivotal study in threatened preterm labour is under way, while two further programmes are still in preparation. A reader should also weigh the site-wide footer warning that some products or features described are under development and not CE marked or FDA cleared, which sits awkwardly beside the badge shown on the product page.
Commercial opacity is assumed and unremarkable for a hospital device: no price, no plan, no trial, everything through a sales conversation. The documentary opacity around data is the more substantive gap. The privacy policy covers the website only, with an unfilled template placeholder where the recipients should be listed, and says nothing about the patient data the device collects, nor about hosting, a data processing agreement or subprocessors, even though health data falls under Article 9 of the GDPR.
The publisher itself is identified without ambiguity: legal name, tax number, entry in the Bizkaia commercial register, a named representative and three offices in Spain, although the site publishes no incorporation date. So is the audience: healthcare institutions and clinical research teams, not the general public.
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