-Scanogen Inc., a molecular diagnostics company pioneering next-generation technologies for infectious disease detection, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s rapid assay designed to identify bloodstream infection pathogens directly from patient samples.

The FDA’s Breakthrough Device designation recognizes technologies that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases. This designation is expected to expedite the development and regulatory review of Scanogen’s diagnostic assay, which represents a major advance in the management of sepsis, a condition that affects more than 1.7 million Americans each year and contributes to over 350,000 deaths.

Scanogen’s first product leverages its SMART (Single Molecule And Rapid Tethering) technology platform to enable rapid, accurate, and cost-effective detection of infectious diseases. The company’s flagship assay targets bloodstream infections in sepsis patients, delivering species-level identification results in just two hours—a dramatic improvement over the one to five days typically required by current blood culture–based methods.

By enabling timely and targeted antimicrobial therapy, the test is expected to significantly improve patient outcomes, curb the overuse of broad-spectrum antibiotics, and reduce hospital costs. With sepsis care exceeding $50 billion annually in the U.S., Scanogen’s technology could generate substantial healthcare savings while transforming the standard of care for infection management.

“This FDA recognition underscores the clinical need for faster, more accurate sepsis diagnostics and validates the potential impact of our platform,” said Dr. Al Celedon, Founder and CEO of Scanogen. “Our goal is to empower clinicians with actionable results in hours rather than days—because every hour counts when treating sepsis.”

In addition to the FDA’s designation, Scanogen has secured multiple research grants from the National Institutes of Health (NIH) supporting the development of its SMART platform and its clinical validation. The company is now raising a Series A round to fund pivotal clinical studies and advance the technology toward market launch.