LifePlus is touting clinical validation for LifeLeaf, a non-invasive and cuffless wearable for continuous glucose and blood pressure tracking. Tested in global multi-center trials, the device reportedly delivers real-time insights without needles, invasive sensors, or cuffs, setting a new standard in scalable, preventive care management.

The purported world-first product was tested at various sites, including the Mayo Clinic, AMCR Clinic (San Diego), Cleveland Clinic (Abu Dhabi), and Hospital Sebarang Jaya (Penang, Malaysia).

“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 in Rochester, Minn. “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.”

LifePlus has collected and analyzed over 70,000 paired multi-biomarker datapoints from more than 500 human subjects across 14 countries and four 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,” LifePlus Chief Operating Officer/Product General Manager Ben Mbouombouo stated.

LifePlus has already conducted multiple clinical studies to demonstrate clinical validation for LifeLeaf. LifeLeaf’s performance vs. continuous glucose monitoring 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. Key highlights follow.

Glucose Monitoring

In head-to-head studies, LifeLeaf achieved a 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.

Blood Pressure

The cuffless blood pressure feature of LifeLeaf demonstrated 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 clinicians worldwide to establish a new longitudinal metric for assessing arterial stiffness that may better predict long-term effects of hypertension and related cardiovascular outcomes.

LifeLeaf does not require needles, cuffs, or calibration as opposed to current solutions. 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, according to the company.

“The results presented show that LifeLeaf has the potential to provide accurate data, without invasiveness or complexity,” said Dr. Timothy S. Bailey of Headlands Research – AMCR Clinic in Escondido, Calif., and Dr. Jerome S. Fischer of MDRequest in San Antonio, Texas. “This kind of non-invasive monitoring is uniquely poised to improve patient adherence and enable earlier detection—two critical factors in managing chronic conditions.”

LifePlus is currently initiating additional longitudinal outcome studies for LifeLeaf across Asia, Europe, Middle East, and North America, focusing on prediabetic and hypertensive populations. The goal is to prove that continuous passive monitoring can lead to earlier interventions and measurable reductions in chronic disease incidence.

“We’re incredibly encouraged by the clinical validation at world-class institutions like Mayo Clinic and Cleveland Clinic,” LifePlus Co-Founder/CEO Dr. Alodeep Sanyal stated. “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.”

With global spending on diabetes and cardiovascular care projected to exceed $1.5 trillion annually by 2030, the market is primed for solutions that extend beyond reactive treatment. LifeLeaf reportedly is the first clinically validated solution of its kind in this space, targeting a more than $100 billion total addressable market.

Silicon Valley-based LifePlus developed LifeLeaf, the world’s first non-invasive, effortless, wrist-worn medical device and platform for continuous, real-time remote patient monitoring. Powered by artificial intelligence, this technology empowers individuals with real-time insights into their vital health parameters, enabling proactive health management, early intervention, and seamless information sharing with loved ones and care teams. Designed for the billions worldwide at risk of chronic diseases, LifePlus is redefining everyday health monitoring.

References
¹ Improved accuracy of a fully non-invasive continuous glucose monitor in a diverse population. T. Bailey et al. American Diabetes Association (ADA) Annual Meeting 2025.
² The feasibility of non-invasive continuous glucose monitoring with the novel LifeLeaf wristwatch and platform. T. Bailey et al. Advanced Technology and Treatment in Diabetes (ATTD) Annual Meeting 2023.
³ The feasibility of cuffless, non-occlusive blood pressure assessments using the novel LifeLeaf wristwatch and platform. European Society of Hypertension (ESH) Annual Meeting 2023.