NuraLogix has announced that it has received 510(k) clearance from the FDA for its Anura Mobile Cor SDK, for the contactless measurement of heart/pulse rate and breath/respiration rate in adults. With this clearance, the technology can be used for in healthcare for adults 18 years of age and above, but is not designed to treat or diagnose patients.
FDA clearance (K253650) 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 analyses subtle facial blood-flow signals captured by a standard camera, enabling contactless measurements without wearables, cuffs, sensors, or specialised hardware.
The company claims this clearance marks an important regulatory milestone for TOI-powered, non-invasive spot measurement of pulse and respiration rates in adults. 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 specialised hardware,” said Marzio Pozzuoli, CEO of NuraLogix. “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 users 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 company says the clearance supports integration into digital health, telehealth and remote care workflows where organisations 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.
The Anura software platform is used across a number of NuraLogix solutions, including MagicMirror and the newly announced Longevity Mirror, unveiled at CES 2026. The FDA 510(k) clearance applies specifically to the Anura Mobile Core SDK for non-invasive spot measurement of pulse rate and breathing rate in adults.
