SANTA ANA, California, June 16, 2026
Autonomous Medical Devices Incorporated (AMDI) announced that the U.S. Food and Drug Administration (FDA) has granted both 510(k) clearance and CLIA waiver for its AMDI Fast PCR System and Mini Respiratory Panel, enabling healthcare providers to perform high-quality molecular respiratory testing and receive results in less than 10 minutes. The newly authorized multiplex RT-PCR assay simultaneously detects and differentiates Respiratory Syncytial Virus (RSV), Influenza A, Influenza B, and SARS-CoV-2 from anterior nasal swab specimens. The milestone positions AMDI among a select group of diagnostics companies delivering rapid, laboratory-quality molecular testing directly at the point of care, helping clinicians make timely treatment decisions while patients remain in the clinic.
FDA Authorization Expands Access to Rapid Molecular Diagnostics
The dual FDA 510(k) clearance and CLIA waiver validates both the performance and ease of use of the AMDI Fast PCR platform for decentralized healthcare environments. According to AMDI, the regulatory strategy was designed to ensure the system could be widely deployed across urgent care centers, physician offices, primary care facilities, and retail clinics without the complexity typically associated with laboratory-based molecular testing. The platform supports the company’s Time of Care™ approach, allowing providers to obtain actionable diagnostic information during the patient visit rather than relying on delayed laboratory results. Company executives noted that extensive manufacturing scale-up efforts have already been completed to support commercial deployment, with production capacity established for both instruments and consumables to meet anticipated market demand.
Mini Respiratory Panel Targets RSV, Flu and COVID-19 Detection
The FDA-cleared AMDI Mini Respiratory Panel is a 4-plex molecular assay designed to identify some of the most common respiratory pathogens responsible for seasonal outbreaks and acute respiratory illness. The panel includes detection of RSV, a significant cause of respiratory disease among infants, older adults, and immunocompromised patients, alongside Influenza A, Influenza B, and SARS-CoV-2. Rapid identification of these viruses can support improved clinical decision-making, patient management, and infection control strategies. Clinical investigators involved with the evaluation highlighted the system’s streamlined workflow, emphasizing that healthcare staff can perform testing without disrupting clinic operations while obtaining highly reliable molecular results during the patient encounter.
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Proprietary Technology Supports Future Menu Expansion
The AMDI Fast PCR System is designed and manufactured in California using the company’s proprietary HBH technology and ultrafast PCR architecture. Beyond its current respiratory testing capabilities, the platform has been developed with scalability in mind, supporting expansion to testing menus of up to 32-plex molecular assays in the future. Additional features include cloud connectivity, enterprise-wide operational visibility, and broad electronic health record (EHR) integration, enabling healthcare organizations to manage testing across distributed networks. Operating from its ISO 13485-certified 110,000-square-foot facility in Santa Ana, AMDI continues to invest in next-generation diagnostic technologies aimed at increasing access to rapid, accurate molecular testing. With FDA authorization now secured, the company is positioned to strengthen the growing market for decentralized diagnostics while improving the speed and efficiency of respiratory disease detection across healthcare settings.
Source: AMDI press release
