Silicon Valley startup LifePlus has announced the clinical validation of LifeLeaf®, positioning it as the world's first non-invasive and cuffless wearable device capable of continuous glucose and blood pressure monitoring. The breakthrough technology underwent testing in global multi-center trials at prestigious institutions including Mayo Clinic, AMCR Clinic in San Diego, Cleveland Clinic in Abu Dhabi, and Hospital Sebarang Jaya in Penang, Malaysia.
Clinical Performance Demonstrates Competitive Accuracy
The device achieved remarkable precision in glucose monitoring studies, recording a 10.8% mean absolute relative difference (MARD) against blood glucose meter (BGM) references and an 8.5% MARD against Dexcom G6 for a target dynamic range of 70-250 mg/dL. These results demonstrate that non-invasive glucose monitoring is not only feasible but viable for real-world clinical applications.
LifeLeaf also maintained a low 2% outlier rate in blinded continuous glucose monitoring studies, performance comparable to invasive alternatives and highlighting its clinical reliability. The device's blood pressure monitoring capabilities showed impressive accuracy with a mean difference ± standard deviation of −0.02 ± 12.5 mmHg for systolic and 0.03± 8.4 mmHg for diastolic measurements across a supported dynamic range of 90/55-170/110 mmHg.
"LifeLeaf delivers clinically validated performance without the usual barriers of needles, cuffs, or cost," said Dr. Samuel J. Asirvatham and Dr. Narayan G. Kowlgi of Cardiovascular Medicine at Mayo Clinic, Rochester, MN. "By making blood pressure and glucose monitoring effortless and non-invasive, it drives better patient adherence, which is crucial for managing chronic conditions like hypertension and diabetes."
Comprehensive Global Dataset Powers AI Development
LifePlus has assembled an extensive clinical database comprising over 70,000 paired multi-biomarker datapoints from more than 500 human subjects across 14 countries and 4 continents. This robust dataset spans diverse demographics including skin tone, age, gender, and BMI, supporting the development of proprietary signal processing and highly generalizable multi-biomarker advanced AI/ML algorithms and models, according to Ben Mbouombouo, Chief Operating Officer and Product GM of LifePlus.
The comprehensive data collection enables the device to function without requiring needles, cuffs, or calibration procedures that current monitoring solutions demand. LifePlus reports the device is 70% more cost-effective over a 12-month period while supporting effortless daily use, factors critical for maintaining high patient adherence and delivering preventive insights.
Clinical Validation Results Presented at Major Medical Conferences
LifePlus has systematically presented clinical validation data at leading medical conferences. The most recent glucose monitoring performance results were showcased at the American Diabetes Association (ADA) Meeting in June 2025, while earlier LifeLeaf performance data against continuous glucose monitors was shared at the Advanced Technology and Treatment for Diabetes (ATTD) meeting in 2023. Blood pressure validation results were published at the European Society of Hypertension meeting in 2023.
"The results presented at ADA this year show that LifeLeaf has the potential to provide accurate data, without invasiveness or complexity," said Dr. Timothy S. Bailey of Headlands Research – AMCR Clinic, Escondido, CA, and Dr. Jerome S. Fischer of MDRequest, San Antonio, TX. "This kind of non-invasive monitoring is uniquely poised to improve patient adherence and enable earlier detection – two critical factors in managing chronic conditions."
Expanding Clinical Program Targets Chronic Disease Prevention
LifePlus is initiating additional longitudinal outcome studies for LifeLeaf across Asia, Europe, Middle East and North America, focusing specifically on prediabetic and hypertensive populations. The company aims to demonstrate that continuous, passive monitoring can lead to earlier interventions and measurable reductions in chronic disease incidence.
The device offers continuous, real-world blood pressure monitoring as opposed to traditional ambulatory monitors that provide limited data points. LifePlus is collaborating with leading clinicians to establish new longitudinal metrics for assessing arterial stiffness that may better predict long-term effects of hypertension and related cardiovascular outcomes.
Market Opportunity Addresses Growing Healthcare Costs
With global spending on diabetes and cardiovascular care projected to exceed $1.5 trillion annually by 2030, the market demand for preventive solutions continues to expand. LifeLeaf represents the first clinically validated solution of its kind in this space, targeting a total addressable market exceeding $100 billion.
"We're incredibly encouraged by the clinical validation at world-class institutions like Mayo Clinic and Cleveland Clinic," said Dr. Alodeep Sanyal, co-founder and CEO of LifePlus. "It confirms what we have believed from the beginning: that non-invasive, AI-powered monitoring can be reliable and scalable. The growing global interest from healthcare providers, partners and investors reaffirms that we are at the forefront of a major shift in how we manage and prevent chronic disease."
