Imagine a smart sensor that can tell if a pregnant woman is actually in early labor or just having a false alarm. Instead of relying on guesswork, it uses special sound waves to feel the stiffness of the cervix, similar to how you might check if a fruit is ripe. An AI then analyzes this feel to give a fast, objective answer right at the bedside.
Current methods for detecting true preterm labor are ineffective, leading to unnecessary hospitalizations and wasted medical resources for millions of women annually.
A point-of-care diagnostic system consisting of a patented intravaginal probe, AI algorithms, and a cloud-based data management platform.
If you are a diagnostic equipment provider dealing with the lack of objective tools for preterm labor, this project developed a patented intravaginal probe and AI software that identifies true TPTL events in real-time. This allows for the creation of a new product line for prenatal clinics.
If you are a hospital chain dealing with high hospitalization rates and economic burdens from 45M annual TPTL cases, this project developed a PoC device that optimizes resource allocation. It helps avoid unnecessary treatments by definitively differentiating true from false labor.
If you are a cloud provider dealing with the need for specialized medical data management, this project developed an online cloud platform and transversal database for cervical tissue analysis. This provides a scalable infrastructure for managing AI-driven diagnostic data.
Based on available project data, specific pricing for the end-user is not mentioned, though the company sought €2.5M for development and validation.
The project focuses on design, production, and securing CE certification to enable European marketing and industrial-scale deployment.
The solution includes a patented intravaginal probe and proprietary AI algorithms developed by Innitius.
The project is pursuing CE certification for Europe and has completed FDA pre-submission tasks, including a Q-Sub supplement and clinical strategy protocols.
The project period runs from 2023-04-01 to 2026-03-31, with the goal of obtaining regulatory approval during this window.
The project is led by a single Spanish SME, Ultrasound-Innovation Medtech (Innitius), resulting in a 100% industry ratio. This lean structure suggests a fast-track commercialization approach, focusing on direct ownership of the IP and a streamlined path from clinical validation to market entry without the complexity of academic partnerships.
Contact Ultrasound-Innovation Medtech Sociedad Limitada in Spain
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