June 16, 2026
AMDI Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel
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Transform global human health through innovative and accessible diagnostic solutions.
Autonomous Medical Devices Incorporated (AMDI) is a California-based company employing a world-class team of engineers, scientists, clinicians, and manufacturing and quality/regulatory experts dedicated to the development and manufacture of best-in-class diagnostic devices using innovative technology, factory automation, and cloud connectivity. AMDI is headquartered in Santa Ana, CA, where it manufactures the Fast PCR Mini Respiratory Panel in an ISO 13485/MDSAP-certified 110,000 square foot facility.
Create patient-centric and cloud-connected diagnostics that provide actionable information within minutes.

Put patients first in all decisions.
Anticipate patient and customer needs.
Empower healthcare systems to deliver quality care to patients with our fast and cost-efficient solutions.

Foster a culture of continuous improvement throughout our business.
Encourage exploration of unconventional and novel ideas that lead to superior customer solutions.
Maintain a bias toward action to efficiently transform ideas to solutions.

Provide a supportive and diverse workplace.
Foster a cohesive environment of cross-functional teamwork.
Be open to everyone's ideas; provide fair and fact-based feedback.

Interact in an honest, trustworthy, and transparent manner.
Deliver on commitments.
Practice diligence and deliver high-quality work.

June 16, 2026
AMDI Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel
READ MORESeptember 15, 2025
AMDI Submits 510(k) and CLIA Waiver Dual Submission to FDA
READ MOREJune 5, 2025
AMDI Completes Clinical Study for Sub-10-Minute AMDI Fast PCR System and Secures MDSAP Certification
READ MOREApril 14, 2025
AMDI Launches Autolab™ HBH at ESCMID 2025, Redefining Sample Prep for Molecular Diagnostics
READ MOREFebruary 28, 2024
AMDI Receives a $5.3M NIH RADx® Tech Award to Finalize Development of Its 10 Minute RT-PCR Point-of-Care System and Respiratory Panel
READ MOREApril 12, 2023
AMDI Receives NIH RADx® Tech Funding to Advance Its 10 Minute RT-PCR Point-of-Care System
READ MORESeptember 20, 2022
Data Highlights the Quantitative Detection of Neutralizing Activity Against Multiple SARS-CoV-2 Variants in Less Than 20 Minute Q-NAb Test
READ MORESeptember 7, 2022
AMDI Achieves ISO 13485:2016 Certification In Anticipation of Commercializing Products in 2023
READ MOREFor media inquiries, contact us.
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