CareFlow AI Receives FDA Clearance for First Primary Care Triage Platform with Autonomous Risk Assessment
BOSTON, Nov. 23, 2025 – CareFlow AI today announced U.S. Food and Drug Administration 510(k) clearance for its CareFlow Triage Pro platform, marking the first regulatory authorization for an artificial intelligence system that provides autonomous risk assessment and care navigation specifically designed for primary care settings. The clearance validates the platform’s ability to safely analyze patient-reported symptoms and automatically route individuals to appropriate care pathways without requiring immediate human triage intervention.
The authorization arrives as primary care practices confront unprecedented operational strain. Patient demand has increased 15% annually while the Association of American Medical Colleges projects a shortage of up to 48,000 primary care physicians by 2034. Current manual triage processes contribute to morning bottleneck spikes, with phone lines jamming during 8 a.m. demand surges and administrative staff spending 60% of their time on intake coordination rather than direct patient care. This imbalance creates cascading delays, with average appointment wait times reaching 11 days in urban markets and patient satisfaction scores declining 12% year-over-year.
Clinical validation studies demonstrate the platform’s efficacy and safety profile. Research published in government-backed health informatics journals shows AI triage systems can reduce mis-triage rates by 25% while maintaining 95.8% clinical agreement with physician assessments. Real-world implementations have delivered measurable outcomes: practices using autonomous triage report 47% reductions in peak-hour call volumes and shift 82% of patient requests to automated online channels, cutting administrative burden significantly. An NHS-commissioned evaluation found AI triage reduced patient wait times by 73%, from 11 days to 3 days, while automating 91% of appointment bookings within clinician-defined protocols.
“This clearance represents a watershed moment for primary care delivery,” said Dr. Sarah Chen, CEO and co-founder of CareFlow AI. “For the first time, health systems can deploy AI that doesn’t just assist clinicians but safely handles routine triage autonomously, freeing our nation’s overwhelmed primary care providers to focus on complex cases that truly require their expertise. The data proves we can maintain clinical rigor while restoring efficiency to the front door of healthcare.”
CareFlow Triage Pro integrates with major electronic health record systems including Epic, Cerner, and athenahealth through FHIR-standard APIs. The platform uses natural language processing to interpret free-text symptom descriptions and applies machine learning algorithms trained on 2.3 million patient encounters across diverse demographics. The system operates within clinician-defined safety parameters, automatically escalating high-risk presentations—including sepsis indicators, chest pain, or cancer red flags—for immediate human review. All patient data is encrypted in transit and at rest, maintaining strict HIPAA compliance and HITRUST certification.
The platform will be available for commercial deployment starting January 2026, with early adopters including three regional health systems covering 340 primary care clinics across the Northeast and Midwest. CareFlow AI projects that full-scale deployment could save the average primary care practice $180,000 annually in administrative costs while reducing patient wait times to under four days. The company has established a clinical advisory board comprising primary care physicians from Johns Hopkins, Mayo Clinic, and UCSF to oversee ongoing algorithm refinement and bias monitoring.
About CareFlow AI
Founded in 2022 by clinicians from Massachusetts General Hospital and AI researchers from MIT, CareFlow AI develops autonomous clinical decision support tools designed to restore efficiency to primary care delivery. The company has raised $47 million in Series B funding and currently serves healthcare organizations across 12 states. Its mission is to eliminate administrative burden from frontline providers while maintaining the highest standards of patient safety and clinical excellence. For more information
Media Contact:
Sarha Al-Mansoori
Director of Corporate Communications
G42
Email: media@g42.ai
Phone: +971 2555 0100
Website:www.g42.ai
