FDA Clears NuraLogix’s Anura Mobile Core SDK for Heart, Respiration Rate Measurement

NuraLogix has earned U.S. Food and Drug Administration 510(k) clearance for its Anura Mobile Core SDK, which measures heart/pulse and breath/respiration rates in adults. The authorization allows the technology to be used for adults ages 18 and older when the subject is relaxed, still and seated upright, but it is not designed to treat or diagnose patients.  

The FDA clearance covers the Anura Mobile Core SDK’s ability to measure pulse rate and respiration rate using NuraLogix’s patented Transdermal Optical Imaging (TOI) technology. TOI analyzes subtle facial blood-flow signals captured by a standard camera, enabling contactless measurements without wearables, cuffs, sensors, or specialized hardware. While the clearance applies specifically to these two measurements within the Anura Mobile Core SDK, TOI also serves as the foundational technology behind NuraLogix’s broader contactless health and wellness platform.

“NuraLogix was founded on the belief that meaningful health insights should be easier to access, easier to scale and less dependent on specialized hardware,” NuraLogix CEO Marzio Pozzuoli said. “Receiving FDA 510(k) clearance for the Anura Mobile Core SDK is a major milestone for our company and for the broader adoption of camera-based health measurement. It reinforces the clinical potential of our TOI technology and supports our mission to make health assessment more accessible across everyday devices and care settings.”

The Anura Mobile Core SDK enables developers, healthcare organizations, and enterprise partners to integrate contactless vital sign measurement into applications using standard devices such as smartphones, tablets, and laptops. Users complete a short facial video scan, with the technology measuring cleared vital signs, including pulse rate and respiration rate, in approximately 30 seconds.

The clearance supports integration into digital health, telehealth, and remote care workflows where organizations need scalable ways to collect basic physiological measurements without requiring additional patient hardware. It also provides a foundation for NuraLogix partners seeking to integrate camera-based vital sign measurement into existing clinical and consumer health experiences, according to the company.

NuraLogix has built its platform using a large and growing dataset of patient scans and has supported its technology through peer-reviewed research, patents and global commercial partnerships. The company’s broader Anura platform is designed to deliver health insights through a simple face scan, supporting applications across healthcare, insurance, corporate wellness, retail health and connected devices.

The Anura software platform is used across several NuraLogix solutions, including MagicMirror and the newly announced Longevity Mirror, unveiled at CES 2026, where it received industry recognition including TechRadar’s Best of CES. The FDA 510(k) clearance applies specifically to the Anura Mobile Core SDK for non-invasive pulse rate and breathing rate spot measurements in adults.

NuraLogix is a global developer of contactless health insights and the creator of patented Transdermal Optical Imaging technology. The company’s Anura platform uses a standard camera to analyze facial blood-flow information and generate health measurements and insights from a short video scan. NuraLogix technology is designed for integration across smartphones, tablets, laptops, kiosks, connected devices and enterprise applications, supporting scalable health assessment across healthcare, wellness and digital health environments.