R44MH142191↗

Openbci, Inc.: all federal awards · Department of Health and Human Services: spending

AFFORDABLE, FDA-CLEARED BIOAMPLIFIER: REMOVING BARRIERS TO SCALABLE EEG AND MULTIMODAL PHYSIOLOGICAL MONITORING - BIOAMPLIFIERS HAVE REVOLUTIONIZED HEALTHCARE OVER THE PAST CENTURY BY ENABLING TRANSFORMATIVE DIAGNOSTIC AND THERAPEUTIC TOOLS. AMONG THESE, EEG HAS EMERGED AS THE MOST WIDELY UTILIZED NEUROIMAGING MODALITY, CRITICAL FOR RESEARCHING, DIAGNOSING, AND TREATING A WIDE RANGE OF MENTAL HEALTH AND NEUROLOGICAL DISORDERS. RECENT ADVANCEMENTS IN WEARABLE ELECTRONICS HAVE EXPANDED THE POTENTIAL OF EEG DEVICES, SHIFTING FROM CUMBERSOME DESKTOP MACHINES AND WET ELECTRODES TO USER-FRIENDLY, WEARABLE DEVICES WITH COMFORTABLE DRY ELECTRODES SUITABLE FOR LONG-TERM, AMBULATORY USE. DESPITE THESE TECHNOLOGICAL ADVANCEMENTS, THE WIDESPREAD DEPLOYMENT OF CLINICAL-GRADE EEG SYSTEMS REMAINS LIMITED BY HIGH COSTS, PROPRIETARY TECHNOLOGIES, AND NON-ADAPTABLE HARDWARE. SIMILARLY, MED-TECH AND NEURO-TECH STARTUPS OFTEN STRUGGLE TO ACCESS AFFORDABLE, REGULATORY-COMPLIANT TOOLS FOR PRODUCT VALIDATION AND MARKET ENTRY, FREQUENTLY FAILING DURING THE “VALLEY OF DEATH” - THE CRITICAL STAGE IN DEVELOPMENT WHERE FUNDING IS REQUIRED TO MEET BOTH REGULATORY AND MARKET DEMANDS. OPENBCI AIMS TO ADDRESS THESE CHALLENGES WITH CYTON V2, THE FIRST AFFORDABLE, FDA-CLEARED BIOAMPLIFIER FEATURING OPEN-SOURCE HARDWARE AND SOFTWARE. BUILDING ON OPENBCI’S LEGACY OF PIONEERING OPEN-SOURCE PHYSIOLOGICAL MONITORING, CYTON V2 WILL BE A MEDICAL-GRADE, ADAPTABLE, AND REPAIRABLE BIOAMPLIFIER SYSTEM. IT IS DESIGNED TO MEET THE NEEDS OF COST-CONSCIOUS RESEARCHERS AND CLINICIANS, WHILE ALSO PROVIDING REGULATORY-COMPLIANT TOOLS TO SUPPORT MEDICAL TECHNOLOGY INNOVATORS DEVELOPING NEW HEALTHCARE SOLUTIONS THROUGH PHYSIOLOGICAL MONITORING. THE OUTCOME OF THIS PROJECT WILL BE A FINISHED BIOAMPLIFIER SYSTEM THAT HAS BEEN TESTED AND CLEARED BY THE FDA FOR INITIAL INDICATION. THE SPECIFIC AIMS OF THIS DIRECT TO PHASE II (D2P2) PROJECT ARE: 1. REFINE BIOAMPLIFIER DESIGN AND TECHNICAL SPECIFICATIONS; 2. DESIGN FOR MANUFACTURABILITY (DFM) AND SCALE-UP MANUFACTURING PROCESSES; 3. VALIDATE BIOAMPLIFIER SYSTEM QUALITY, SAFETY AND PERFORMANCE TO STANDARDS; AND 4. PREPARE AND SUBMIT THE FINAL BIOAMPLIFIER PRODUCT FOR REGULATORY APPROVAL. BY ACHIEVING THESE AIMS, THIS PROJECT WILL MAXIMIZE THE PRACTICAL AVAILABILITY OF MEDICAL-GRADE EEG AND OTHER BIOSENSING TECHNOLOGIES. THESE OUTCOMES WILL ADDRESS CRITICAL GAPS IN NEUROLOGICAL AND MENTAL HEALTH DIAGNOSTICS.

Project Grant (B) · National Institutes of Health · to Openbci, Inc. (UEI EEXZGZLY5LL1) · data as of 2026-10-28

Source: USAspending.gov prime award transactions and FSRS subaward reports, as loaded by SpendQuery (data as of 2026-10-28). Amounts are obligations (money committed), not outlays. The official record on USAspending.gov ↗