Landmark trials at Mayo Clinic and Cleveland Clinic support market adoptions of breakthrough AI-powered wearable for early detection and prevention of chronic diseases

SAN JOSE, Calif.: LifePlus, a Silicon Valley startup redefining personal health monitoring, today announced the clinical validation of LifeLeaf®, the world’s first non-invasive and cuffless wearable for continuous glucose and blood pressure tracking. The device, tested in global multi-center trials including Mayo Clinic, AMCR Clinic – San Diego, CA, Cleveland Clinic – Abu Dhabi, and Hospital Sebarang Jaya – Penang, Malaysia, delivers real-time insights without needles, invasive sensors, or cuffs, setting a new standard in scalable, preventive care management.

“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, 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. This scalable solution has a strong potential to transform care models globally by enabling proactive, patient-friendly disease management.”

Global Dataset

LifePlus has collected and analyzed over 70,000 paired multi-biomarker datapoints from more than 500 human subjects across 14 countries and 4 continents. “This robust dataset spans a wide range of 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,” said Ben Mbouombouo, Chief Operating Officer and Product GM of LifePlus.

Clinical Results

LifePlus has already conducted multiple clinical studies to demonstrate clinical validation for LifeLeaf. The most recent results of its performance vs BGM for glucose monitoring are scheduled to be showcased at the upcoming American Diabetes Association (ADA) Meeting, June 20-23, 2025. Earlier, LifeLeaf’s performance vs CGM was shared at the Advanced Technology and Treatment for Diabetes (ATTD) meeting in 2023. LifePlus also published clinical validation results for blood pressure in the European Society of Hypertension meeting in 2023. Please see key highlights below:

• Glucose Monitoring
  • In head-to-head studies, LifeLeaf achieved an impressive 10.8% MARD against BGM references1 and 8.5% MARD against Dexcom G62 for a target dynamic range of 70-250 mg/dL, demonstrating non-invasive glucose monitoring is not only possible, but viable and scalable for real-world use.
  • LifeLeaf attained a low 2% outlier rate1 in blinded continuous glucose monitoring studies, comparable with invasive alternatives and underscoring its clinical reliability.
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• Blood Pressure
  • The cuffless blood pressure feature of LifeLeaf demonstrated impressive accuracy, with a mean difference ± standard deviation of –0.02 ± 12.5 mmHg for systolic and 0.03± 8.4 mmHg for diastolic measurements3 for a supported dynamic range of 90/55-170/110 mmHg, validated across multiple clinical studies and real-world settings.
  • LifeLeaf collected indefinite long-term blood pressure data as opposed to traditional ambulatory monitors, offering continuous, real-world views. LifePlus is engaged with the world’s leading clinicians to establish a new longitudinal metric for assessing arterial stiffness that may better predict long-term effects of hypertension and related cardiovascular outcomes.
  • LifeLeaf is unique because it does not require needles, cuffs, or calibration as current solutions do. It is 70% more cost-effective over a 12-month period and supports effortless daily use, which is critical for maintaining a high degree of patient adherence and delivering preventive insights.