Every breakthrough in healthcare starts with a big idea, but turning that idea into something patients can rely on takes time, evidence, and accurate validation. As we move isaac™ by PreEvnt through clinical trials on its path toward FDA approval, we’d like to offer a window into how medical innovation becomes real. Behind the scenes is a structured, highly disciplined process designed to ensure both safety and impact by the time it gets into the hands of consumers.

The path we’re on - “FDA Pre-Submission” 

Long before a device ever reaches the FDA for formal review, there’s a quieter but equally important phase where the foundation is set. Pre-submission is an early conversation where a company begins to share how the technology works, how it plans to validate it, and what success should look like in a clinical setting. In return, the FDA provides guidance that can shape everything that follows.

For a technology like isaac, that dialogue is especially important because we’re introducing a fundamentally different approach to monitoring metabolic health using breath analysis to detect biomarkers like acetone and correlate them to glucose trends. That kind of shift requires alignment early, ensuring that both the science and the validation strategy meet the standards expected for a new category of device.

In many ways, pre-submission is where innovation becomes structured. It transforms a promising idea into a clearly defined path that can be tested, measured, and ultimately trusted.  And while it happens behind the scenes, it’s one of the most critical steps in bringing a new medical technology closer to reality.

The path to FDA clearance isn’t one-size-fits-all, but most devices follow a similar progression:

1. Concept & Early Development
This is where the core technology is built and tested in controlled environments. For isaac, that meant developing a compact, wearable system paired with a mobile app capable of delivering real-time alerts and insights.

2. Clinical Validation
Once the technology is stable, it must be tested by humans. These studies evaluate how well the device performs compared to existing standards. isaac is currently in clinical trials at Indiana University, where its readings are being compared to traditional glucose monitoring methods across different patient populations. This step is essential because it’s where innovation meets real-world variability.

3. Data Collection & Analysis
The FDA doesn’t just want results; it wants statistically meaningful evidence. Companies must demonstrate accuracy, reliability, and consistency across a wide range of use cases.

4. FDA Submission
Only after sufficient data is gathered does a company formally submit its application. This includes clinical results, engineering documentation, risk analyses, and usability data. We’re working to get isaac to this state by late 2026.

5. FDA Review & Decision
The FDA evaluates whether the device is safe and effective for its intended use. Depending on the device type, this may result in clearance (for devices similar to existing ones) or approval (for entirely new categories).

Clinical validation is often the longest and most complex part of the journey - and for good reason.

Human biology is unpredictable. Factors like age, lifestyle, coexisting conditions, and environmental variables can influence results. For a device like isaac, which interprets metabolic signals from breath, the challenge is even greater: it must correlate indirect biomarkers with blood glucose levels across diverse users.

That’s why trials are designed to expand over time, starting with specific populations and broadening to include others. Early isaac studies, for example, began with adolescents with Type 1 diabetes before expanding to adults with Type 2 diabetes.

Validation also extends beyond the device itself. The accompanying app, responsible for tracking results, generating reports, and delivering alerts, must meet usability and reliability standards that support both patients and clinicians. In short, every part of the ecosystem must work together seamlessly.

While the FDA process can feel lengthy, it plays a critical role in building trust.

For patients, it means confidence that a device will perform as expected.
For clinicians, it ensures data can be relied upon in care decisions.
For innovators, it creates a structured pathway to bring meaningful advancements to market.

The goal with isaac is ambitious: to offer a non-invasive, accessible way to monitor a person’s metabolic health; providing a tool for Type-2 and Prediabetics to learn how their bodies react to diet and exercise.  But achieving that goal responsibly requires more than innovation. It requires proof.

That’s what this journey is all about.