NuraLogix Anura Mobile Core® SDK Receives FDA 510(k) Clearance for Contactless Measurement of Heart/Pulse Rate and Breath/Respiration Rate
Clearance covers the use of NuraLogix’s patented Transdermal Optical Imaging technology to measure key vital signs from a 30-second facial video scan
Toronto, ON – June 16, 2026 – NuraLogix, a global leader in contactless health insights, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Anura Mobile Core® SDK for the contactless measurement of heart/pulse rate and breath/respiration rate in adults. With this clearance this 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 analyzes subtle facial blood-flow signals captured by a standard camera, enabling contactless measurements without wearables, cuffs, sensors, or specialized hardware.
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 specialized 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 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.
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 a number of 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 spot measurement of pulse rate and breathing rate in adults.
The Anura Mobile Core® SDK is available now for integration.
For more information, please contact: info@nuralogix.ai
About NuraLogix
NuraLogix is a global leader in 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.
Regulatory note: FDA 510(k) clearance K253650 applies to the Anura Mobile Core SDK for non-invasive spot measurement of pulse rate and breathing rate in adults when the subject is relaxed, still and seated upright. The device is intended for general healthcare use and is not designed to diagnose or treat patients. Other Anura health insights are intended for wellness, recreation, or research unless separately cleared, authorized or approved for medical use.