SANTA ANA, Calif., June 16, 2026 /PRNewswire/ — Autonomous Medical Devices Incorporated (AMDI) today announced that the U.S. Food and Drug Administration has granted both 510(k) clearance and CLIA waiver for the AMDI Fast PCR Instrument and Mini Respiratory Panel, a multiplex RT-PCR test for the simultaneous detection and differentiation of Respiratory Syncytial Virus (RSV), Influenza A, Influenza B, and SARS-CoV-2 from anterior nasal swab specimens. The Fast PCR System delivers sample-to-answer RT-PCR results in under 10 minutes, helping providers act within the Time of Care™ during urgent care and physician office visits.

“This milestone reflects the coordinated work of teams across AMDI,” said Aiying Sun, EVP, Quality, Regulatory and Clinical Affairs at AMDI. “Pursuing the FDA’s dual 510(k) clearance and CLIA waiver pathway was a deliberate strategy to bring this innovation to market with the validation needed for clinical use in the urgent care setting. It shows that Fast PCR combines strong RT-PCR performance with the simplicity needed for confident molecular testing at the point of care.”

“AMDI has scaled manufacturing for both instruments and consumables to support broad deployment,” said Frank Gill, COO of AMDI. “We have the capacity, quality systems, and supply discipline required to support long-term adoption with confidence.”