NIVA

Heart failure risk assessment lacks an easy, accurate way to measure volume overload, leaving gaps in patient monitoring and care.

Congestive heart failure is the leading cause of hospital admissions in the United States. While clinicians can assess a patient’s risk based on medical history and physical symptoms, directly measuring volume overload—a key indicator of heart failure—is difficult. Invasive methods provide accuracy but come with risks, while existing non-invasive methods are indirect and often unreliable.

Imagine if a clinician couldn’t read an active pulse or measure blood pressure—critical tools for assessing patient health. The lack of an easy, accurate way to monitor congestion in-home, in clinics, and in hospitals leaves dangerous gaps in care.

Volumetrix developed a breakthrough technology to non-invasively measure extracellular fluid volume, providing real-time hemodynamic insights that can detect volume overload before it becomes life-threatening. However, they needed a scalable, user-friendly device to bring this innovation to market.

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Designing a Commercial-Ready Medical Device Within Strict Constraints.

Ovyl partnered with Volumetrix to transform their proprietary technology into a practical, scalable medical device. Our work encompassed industrial design, mechanical engineering, and circuit design, ensuring that the final product met both medical and usability requirements.

To make the device effective and accessible, we designed within several critical constraints:

• Integrated On-Device Screen: The device needed to display results directly rather than relying on an external phone or tablet app.
• Optimized Armband Design: The device had to be easy to position correctly and apply the right amount of pressure for consistent readings.
• Medical-Grade Durability: Materials had to be easy to clean, highly durable, and compliant with medical device standards.
• Brand Alignment: The industrial design needed to align with the Volumetrix brand while maintaining a professional, high-tech aesthetic.

Through iterative prototyping and refinement, Ovyl delivered a device that was not only technically sound but also user-friendly and scalable for commercialization.

A Non-Invasive Breakthrough in Hemodynamic Assessment.

The final product is a revolutionary blood volume measurement device that enhances heart failure monitoring in three key ways:

• Signal Capture: NIVA technology non-invasively captures the venous waveform, an energy-based signal within the body that reflects numerous physiological conditions, providing real-time insight into volume status and congestion in heart failure patients.
• Signal Deconstruction: By analyzing multiple component frequencies within the venous waveform, NIVA can individually identify and map both the frequencies and amplitudes of these signals.
• Signal Decoding: A proprietary algorithm translates the waveform data into a simple NIVA score, providing healthcare professionals and patients with a reliable, easy-to-understand measure of volume status that corresponds to PCWP, a widely recognized clinical assessment.

NIVA’s non-invasive approach revolutionizes heart failure monitoring, offering a new level of accessibility, accuracy, and proactive care in both clinical and home settings.