Product Information
Device Uses
The Leaf Guardian’s flagship, the PrevenThermTM Monitoring System is a non-contact monitoring device designed to assist in preventing hospital acquired pressure injuries by continuously monitoring, tracking and analyzing patient movement, laying posture and patient’s specific thermal patterns. The system operates 24/7, passively collects information without manual input and automates patient medical records with time stamped notes and pictures. 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 Medical and Surgical ICUs, NICUs, Neuro, IMCU, Trauma Care and Oncology 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 PrevenThermTM Monitoring System.
Our esteemed active collaborators are listed below. These distinguished medical institutes contribute significantly to clinical validation and AI development. We invite new hospital partners who are interested in piloting our cutting-edge technology and customizing it to address their unique requirements.
- GITAM (Gandhi Institute of Technology and Management), India, 2025
- Shady Grove Medical Center, 2026
- White Oak Medical Center, 2027
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.
Web: https://gitamhospital.gitam.edu/
Shady Grove Medical Center
Adventist HealthCare Shady Grove Medical Center is a premier, not-for-profit acute care facility located in Rockville, Maryland, dedicated to extending physical, mental, and spiritual healing. Established in 1979, the hospital stands as the largest facility within the Adventist HealthCare system, serving as a trusted cornerstone of community health for Montgomery County and the surrounding region. Guided by an expert medical staff of over 1,000 physicians and 2,800 dedicated team members, Shady Grove combines cutting-edge clinical innovation with deeply compassionate, patient-centered care.
White Oak Medical Center
Adventist HealthCare White Oak Medical Center is a state-of-the-art, non-profit acute care hospital located in Silver Spring, Maryland, dedicated to delivering comprehensive, faith-based healthcare. Originally founded in 1907 as the Washington Sanitarium (and later known as Washington Adventist Hospital in Takoma Park), the facility relocated in 2019 to a brand-new, $400 million, 48-acre campus within Montgomery County’s emerging Life Sciences Gateway. Serving patients throughout Montgomery, Prince George’s, and surrounding counties, White Oak Medical Center features over 180 all-private inpatient rooms designed to promote holistic healing, combining century-long community roots with cutting-edge medical innovation.
Adventist HealthCare Shady Grove Medical Center
Shady Grove Medical Center is a premier, not-for-profit acute care facility located in Rockville, Maryland, dedicated to extending physical, mental, and spiritual healing. Established in 1979, the hospital stands as the largest facility within the Adventist HealthCare system, serving as a trusted cornerstone of community health for Montgomery County and the surrounding region. Guided by an expert medical staff of over 1,000 physicians and 2,800 dedicated team members, Shady Grove combines cutting-edge clinical innovation with deeply compassionate, patient-centered care.
Certified Innovation
Utility Patents (CIP)
Our innovative technology is granted a CIP utility patent in March 2026. This patent reflects our commitment to delivering a groundbreaking solution for pressure injury prevention.
Details
Title: Monitoring apparatus and method for preventing pressure injuries
Innovators: Marjan Monfarednasab, Shahab Bayani Ahangar, Gregory G. Collier
Publication date: 2026/03/24
Patent No.: US12586243 A1, B2
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 (due to intelligence and influence on diagnosis) and has high probability to 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
Sign Up For Early Access
Thank you for your interest in our upcoming platform. We are inviting potential customers and interested collaborators to join our exclusive waiting list. By submitting your contact information, you will:
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Thank you for your support as we work toward delivering an exceptional product experience.