Product Information
Device Uses
The Leaf Guardian’s flagship, the PrevenTherm Monitoring System is a non-contact monitoring device designed to assist in preventing pressure injuries by continuously monitoring and analyzing patient movement, laying posture and skin health. The system operates 24/7 and passively collects information without manual input. It allows caregivers to identify early signs of risk associated with immobility, blood or lymphatic disruption days before the ulcer formation. Data is analyzed in real-time by a physics-informed AI algorithm, which generates timely alerts when intervention is necessary. The system is intended for use in Intensive Care Units, where timely detection and response are critical to improved patient outcome.
Scientific Evidence
To explore the science behind our innovation and access supporting research, contact us for more information.
Clinical Collaboration
We are actively partnering with hospitals and research institutions to test and refine the Leaf Guardian Monitoring System. Our current collaboration with GITAM (Gandhi Institute of Technology and Management) supports clinical validation and AI development. We welcome new hospital partners interested in piloting our technology and tailoring it to meet their specific needs.
Current Partners
GITAM (Gandhi Institute of Technology and Management)
GITAM is one of India’s premier private universities, with campuses in Visakhapatnam, Hyderabad, and Bengaluru. Its GITAM Institute of Medical Sciences and Research (GIMSR) is a leading teaching hospital and medical college in Andhra Pradesh, featuring an 850-bed multi-specialty hospital supported by over 300 specialists.
As a strategic partner to Leaf Guardian, GITAM plays a vital role in the clinical evaluation of our technology. The GIMSR team supports product testing and data collaboration to refine our machine learning algorithms based on real-world patient monitoring. Their academic and medical expertise ensures that our solution is both innovative and clinically aligned.
Certified Innovation
Patent Pending
Our innovative technology is currently under patent review to ensure the protection of its unique design and functionality. This pending patent reflects our commitment to delivering a groundbreaking solution for pressure injury prevention.
Details
Serial No.: 63/693,300
Ref.: LGN-001PR
FDA
We are preparing a De Novo submission due to the absence of a suitable predicate. Based on our risk analysis and contactless design, we anticipate that the device may ultimately be classified as Class II and could potentially qualify for 510(k) exemption following De Novo review. Final classification and exemption status will depend on FDA’s determination of appropriate special controls.
Details
Product Code: De Novo
Submission Type: 510(k) Exempt, Class II Device
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Leaf Guardian 