Biocogniv receives FDA Breakthrough Designation for its Sepsis aiMarker™


Our AI sees what the eye can't. Before it's too late.

Each year, over 700,000 patients die in US hospitals, and 1 in 20 of those deaths are due to late diagnosis and intervention. We help frontline providers recognize acute conditions before they become irreversible, using state-of-the-art AI and routine tests already performed at hospitals.

our innovation engine

FDA-grade AI, powered by Real World Data

The confluence of large clinical databases and high-performance artificial intelligence (AI) models is enabling a new paradigm in medical diagnostics.

Biocogniv has built proprietary platforms and datasets that power real world evidence of unprecedented scale, allowing us to discover new opportunities without incurring the risk and high cost of traditional clinical trials.

Our first product, Sepsis aiMarker™, can detect and predict sepsis up to 72 hours in advance using only routine laboratory panels collected in the emergency room, and has been awarded a Breakthrough Designation by FDA.

16 Million+
1 Billion+


"Having worked on novel biomarkers for decades, I am genuinely impressed and excited about Biocogniv’s ability to leverage routine blood tests to detect acute conditions before they become obvious. Biocogniv's AI-based biomarkers could soon become part of the standard of care in emergency medicine."

W. Frank Peacock, MD FACEP FACC

Thought leader in acute care biomarkers
Vice Chair, Emergency Medicine Research
Baylor College of Medicine


"I oversee innovation at an organization that employs 5,000 frontline providers at hundreds of hospitals, so we've seen many products. I believe Biocogniv's AI biomarkers are a breakthrough in medicine as they go beyond traditional alerts that merely point out what can be known without them – it identifies what is not clinically evident, as early as possible in the patient trajectory."

Joshua Tamayo-Sarver, MD PhD FACEP

Vice President of Innovation, Vituity
Emergency Physician and Biostatistician
Good Samaritan Hospital, CA


"We have worked on a blinded, independent validation of Biocogniv's digital biomarker, using a large dataset from our 1,000-bed system. The accuracy of the predictions were in excellent agreement with the expected performance of the tool. I think this is going to change how acute conditions are approached by providers."

Peter McCaffrey, MD FCAP

Director, Lab Information Services
Director, Pathology Informatics
University of Texas Medical Branch (UTMB)