Market Dive: Wearable Health Monitoring Devices

Evolving over the last decade from simple step and fitness trackers to AI-powered, always-on health diagnostics, wearable monitoring devices are transforming how chronic conditions such as diabetes, and various heart and neurological diseases are managed—and even treated.

Starting over a decade ago, Fitbit (now part of Google), Apple’s Apple Watch, and Samsung’s Galaxy Watch made wearable fitness tracking mainstream. Now, the medtech industry and health monitoring-first companies have seized on the opportunity, with smart health technology including wrist-worn devices, patches, sensors, headbands, and other products. 

From continuous glucose monitors (CGMs) to AI-driven cardiac patches and sleep apnea sensors used in a variety of healthcare settings, from tech and medtech giants such as Dexcom, Abbott, Medtronic, iRhythm, AliveCor, Omron, ResMed, and BrainBit, among many others including emerging innovators, cutting-edge wearable monitoring devices aren’t just for tracking. They’re now helping to diagnose, predict, guide, and even treat chronic conditions like diabetes and heart disease. Packed with AI-powered analytics and personalized, real-time insights, they’re shifting healthcare from reactive to proactive, slashing chronic disease hospitalizations, and redefining patient outcomes.

With demand for proven always-on wearable health monitoring devices for a variety of conditions surging, and clinical evidence supporting their efficacy, the future of the global wearables market is heading toward more advanced, multi-condition monitoring with deeper AI integration, making healthcare more proactive, personalized, and accessible.

A Multi-Billion-Dollar Market Opportunity

The market for wearable monitoring devices has grown continuously since its inception in 2009 with the launch of Fitbit, with a dramatic expansion in 2015 with the introduction of the Apple Watch, followed by the Samsung Galaxy Watch in 2018. The Apple Watch now accounts for about 86% of the global wearables market. These easy-to-use wearable devices have seen pervasive utilization, with some estimates indicating that over 30% of adults in the U.S. regularly use wearables (Roos & Slavich, 2023). 

Total sales of wearable monitoring devices are projected to increase at a CAGR of 3.6% during the forecast period, from $17.8 billion in 2023 to $21.2 billion in 2028, according to LSI Market Intelligence (see figure on next page). Market growth is primarily driven by increases in price, as newer models featuring advanced software and sensor technologies are introduced, with growth in unit volume contributing 1.5% annually. Since their market entry, new sensors and applications have been implemented in subsequent generations of devices that increase the amount of healthcare data being captured and analyzed. 

Products included within the scope of this LSI analysis include: Wearable devices for physiological monitoring of heart rate, electrocardiograms (ECGs), oxygen saturation, blood pressure, sleep apnea, exercise/exertion, respiration, body temperature, and others. 

A sampling of innovative wearable health monitoring devices by application:

• Continuous Glucose Monitors (CGMs): Considered by providers and patients to be essential for diabetes management, CGMs from companies such as Dexcom (Dexcom G7), Abbott (Freestyle Libre systems), and Medtronic (MiniMed 780G system) provide real-time glucose readings, trend analysis, and alerts to help patients maintain optimal blood sugar levels and prevent health complications. Most CGM devices are designed to help patients manage their Type 1 or 2 diabetes with fewer fingerstick checks. A sensor just under the skin measures glucose levels 24 hours a day, and a transmitter sends results to a wearable device or cell phone to allow users to track changes to their glucose level in real time. Recently, the potential market for CGMs has expanded significantly with the FDA approval of over-the-counter (OTC) CGM devices from Dexcom (the Dexcom Stelo Glucose Biosensor System) and Abbott (Lingo and Libre Rio) in 2024. These devices are marketed toward the general population who are looking to monitor their glucose levels for overall health and wellness.
  
  
• Cardiac Monitoring Wearables: Devices like ECG patches (e.g., iRhythm’s Zio, AliveCor’s Kardia 12L and other models, Hillrom/Bardy Diagnostics’ Carnation Ambulatory Monitor [CAM Patch]) and smartwatches with ECG functionality (e.g., Apple Watch and WithingsScanWatch) help detect arrhythmias, atrial fibrillation (AFib), and other cardiac irregularities to aid in reducing stroke risk and enabling early intervention.
  
  
• Wearable Blood Pressure Monitors: Continuous blood pressure tracking devices, such as those from Omron (the Omron Healthcare Heart Guide BP8000-M Blood Pressure Monitor) and Aktiia (the Aktiia bracelet, cuff, and mobile app), and cuffless technology under development, provide hypertension patients with round-the-clock insights, aiding in better disease management and medication adherence.
  
  
• Respiratory and Sleep Monitors: Devices like ResMed’s AirView-connected continuous positive airway pressure (CPAP) systems and wearable pulse oximeters help manage conditions such as chronic obstructive pulmonary disease (COPD) and sleep apnea, reducing hospital readmissions and improving quality of life.

Neurological Wearables: Smart headbands and electroencephalogram (EEG) wearables, such as those by NeuroMetrix, BrainBit, and Epitel, assist in monitoring neurologic conditions, e.g., stroke (for potential arrhythmia capture), epilepsy, Parkinson’s disease, and sleep disorders. The Quell Fibromyalgia device from NeuroMetrix is the first and only FDA-approved medical device that helps reduce the symptoms of fibromyalgia.

A Transformation in Patient Monitoring

As a tool for monitoring patients, there are many factors influencing market growth in this space. Drivers include a greater volume of data for clinical decision-making, and reduced healthcare costs. 

There is an increasing body of evidence indicating that wearable technologies can reduce healthcare expenditures, through a combination of preventative care (e.g., lowering the impact of lifestyle-related risk factors), reductions in healthcare visits, and a transition from more costly monitoring alternatives. A systematic review by De Sario Velasquez et al. (2024) found that across a broad spectrum of wearable monitoring devices, the probability of these technologies being cost-effective for their respective uses ranged from 66% to 100%. The case for utilizing wearable monitoring devices is expected to increase as more studies are conducted. 

Game-changing, venture-backed wearables in development, such as the “lab in a patch” from Nutromics, which uses DNA sensor technology to track multiple targets in the body such as disease biomarkers and hard-to-dose drugs, offer a glimpse into the potential for this market. 

Another new innovation, Google’s Pixel Watch 3, includes a newly FDA-cleared feature called Loss of Pulse Detection, which can detect impending death due to a stopped heart. 

Continuous monitoring through next-generation wearables represents a transformation in the way patients can be cared for, which would translate to significant market growth if the technology can be actualized. 

Data as Both a Challenge and an Opportunity

The challenge with these technologies remains in helping clinicians decipher the large volume of data to inform, data quality, user retention, and reimbursement, as well as not overwhelming the care delivery process.

Perhaps the most consistently highlighted challenge to the wearable monitoring devices market is the quality of the data being collected. According to broker research by The Benchmark Company, one of the most significant barriers to increased adoption of wearable monitoring devices is the lack of consistent, high-quality data from these devices.

Like other interventions, user retention or compliance is another challenge that limits the success of this market—but it also provides avenues for innovation. Device makers and providers are both invested in ensuring that patients continue to utilize these devices to maximize their benefits. Payors recognize the benefit of wearable monitoring devices, however reimbursement considers the time and resources necessary to monitor and review this large volume of data. 

Other limiters of the wearable health monitoring devices market include the relatively high price for wearable devices, which limits market penetration particularly in less developed regions, and market saturation as the pool of consumers interested in personal health monitoring devices but who have not adopted the technology gradually shrinks.  

The Dominance of Apple

With an estimated 86% market share (see figure), Apple unequivocally leads the market for wearable monitoring devices as the most popular smartwatch in the world. As of 2023, nearly 80% of iPhone users were also Apple Watch owners, according to industry research.

Of all the consumer-focused competitors, Apple has been the most aggressive in obtaining FDA approval for various sensors and monitoring capabilities used in their devices, such as the detection of arrhythmias including Afib. The company clearly has its eyes on making a consumer-focused device that can bring medical-grade data for various vital signs to physicians. 

In terms of units, having reached a peak of 53.9 million units in 2022, sales of Apple Watches declined the following year. In 2023, the company reported that 38.3 million units were sold. Other major market leaders, like Google/Fitbit and Zepp Health (with the Amazfit smartwatches and wearables), have not committed nearly as aggressively towards the positioning of their devices as medical-grade wearables. Like Apple and its Apple Watch, both companies have reported declining sales of their devices. 

Given its accessibility, connectivity to the wider Apple products ecosystem, and focus on implementing additional healthcare-focused features, Apple and its Apple Watch platform is the most dominant wearable monitoring device. The market leader has received FDA approvals for several health-related features on its devices, including the Apple Watch’s AFib history feature, irregular rhythm notification feature, the ECG app, and sleep apnea detection. A new model, the Apple Watch Ultra 3, with enhanced features like hypertension detection, blood pressure tracking, and satellite connectivity, is potentially planned for introduction in September 2025. 

As this market has become saturated with competitors and mature from a unit volume growth perspective, LSI projects that clinical-grade devices are driving underlying market growth in terms of unit and dollar volumes. There are several reasons for this, including clinical-grade devices commanding a higher average selling price and being approved for monitoring and managing some of the most burdensome types of chronic disease (e.g., cardiovascular disease and diabetes). 

While the overall market, which includes consumer- and clinical-grade devices, is projected to expand at a slow rate, the dollar volume of the medical-grade devices market is projected to increase rapidly over the next five years as healthcare providers and payers seek to implement more efficient ways to manage patients. 

Market leaders remain focused on incorporating more advanced health monitoring features into consumer-based devices to transform them into clinical-grade wearables and maintain market share. The most targeted features are for continuous electrocardiogram (ECG) monitoring and blood glucose monitoring. The latter is far more challenging to implement without a more invasive sensor (e.g., microneedles). However, the implementation of diabetes monitoring and therapeutic capabilities would result in being able to service approximately 10% of the global adult population. 

Start-Up Spotlight

Attracted to a large and growing market for wearable health monitoring devices and the potential to impact health outcomes for a variety of chronic diseases in novel ways, many medtech and healthtech start-ups are innovating in this space. A few of our promising LSI alumni presenters are highlighted below.

CGM Tech

Glucomodicum, founded in 2018 as a spin-out of the University of Helsinki in Finland, is transforming glucose monitoring with precise, needle-free magnetohydrodynamic technology. The company’s new CGM sensor, the Talisman, measures glucose molecules diffused through the skin. By integrating ultra-sensitive and low-cost biosensors, Talisman enables continuous, painless, and accurate monitoring of glucose levels. Review Co-Founder and Medical Director Jokke Maki’s LSI Europe ‘24 presentation on the LSI website (Resources > Video Library).
Goleta, CA-based Laxmi Therapeutic Devices was founded in 2016 to improve the quality of life for people living with diabetes. The company is developing a wearable diagnostic device that supports people living with Type I diabetes with real-time, accurate measurements. Review Co-Founder and CEO Sumita Pennathur’s LSI USA ‘24 presentation on the LSI website (Resources > Video Library).

Mental Health Tech

Fisher Wallace Labs is a developer of wearable brain stimulation technologies for the treatment of depression, anxiety, insomnia, and other mental health conditions. Its OAK device uses Transcranial Alternating Current Stimulation (tACS), which modulates brain function and cognitive processes by entraining neural oscillations and inducing long-term synaptic plasticity. Review Co-Founder, CEO and Director Kelly Roman’s LSI USA ‘24 presentation on the LSI website (Resources > Video Library).

Sleep Tech

Onera Health is developing diagnostic and monitoring solutions to help people with sleep-related ailments. The company’s Onera STS wearable sleep system collects comprehensive sleep data which allows providers to optimize patient care and reduce costs. Review Founder and CEO Ruben de Francisco’s LSI Europe ‘22 presentation on the LSI website (Resources > Video Library). (Also see Power Moves and LSI Alumni Milestones, The Lens, February 2025.)

Medication Monitoring

CARI Health is developing a remote medication monitor that will enable clinicians to view medication levels in real-time and customize dosages for every patient. The pain-free, small, wireless sensors are worn on the patient’s skin and continuously send data about medication levels to the CARI Cloud. If medication levels fall outside of the desired range, then alerts may be sent to clinicians, patients, and family members. Review CEO Partik Schmidle’s LSI USA ‘24 presentation on the LSI website (Resources > Video Library).

Neuromodulation Tech

CardiaCare is developing a first-of-its-kind wearable monitoring device that can also provide treatment. Its digital neuromodulation device is designed for patients with atrial fibrillation (AF), that combines proprietary, closed-loop neurostimulation of the median nerve with AI-enabled cardiac monitoring. The app that accompanies the device transforms AF management by providing therapy management, real-time ECG tracking and arrhythmia alerts, continuous vital sign monitoring, and personalized insights into symptoms and triggers. Given AF’s multifactorial nature—often influenced by medical conditions, medications, alcohol, caffeine, sleep apnea, stress, and genetic predisposition—this comprehensive platform for understanding and managing each AF patient with a personalized approach is critical.

The company has recently completed a pilot feasibility trial and is now raising a Series A financing to fund pivotal trials for two indications for its technology, paroxysmal AF and post-ablation, with targets to achieve FDA clearances in 2027. Review CEO Amir Soltanianzadeh’s LSI Europe ‘24 presentation on the LSI website (Resources > Video Library). (Read more about Soltanianzadeh’s story and the company’s technology in “LSI Alumni Innovator Spotlight: CardiaCare CEO Amir Soltanianzadeh,” The Lens, February 2025.)

Cardiac Monitoring Tech

Pulsify Medical is developing a wearable patch, the Pulsify Patch, that utilizes ultrasound to continuously monitor cardiac output and performance. The flexible patch can be worn on the chest for hours or days, and is the first device to continuously and directly monitor cardiac performance, employing an ultrasound sensor. The company is a spinoff from both imec and the Catholic University of Leuven’s Medical Imaging Center. Review the company’s LSI USA ‘23 presentation on the LSI website (Resources > Video Library).

San Jose, CA-based VitalConnect, a leader in biosensor technology, offers the only cardiac monitoring technology, the VitalPatch RTM, that sends all patient data instantaneously to a secure cloud, enabling monitoring for 21 different cardiac arrhythmias and real-time monitoring for four important patient vitals. The flexible, water-resistant, fully disposable VitalPatch RTM requires no assembly or charging, and allows patients to go about their normal daily routine, optimizing compliance over the monitoring period.

In February, the company closed $100 million in financing, through a combination of equity and debt capital. The equity financing was led by new investor Ally Bridge Group, with participation from existing investors including EW Healthcare Partners, MVM and Revelation Partners, while Trinity Capital provided the debt financing. Review Founder and Executive Chairman Nersi Nazari’s LSI USA ‘22 presentation on the LSI website (Resources > Video Library). 

ENT Tech

Washington, DC-based Otolith Labs is developing prescription medical devices for the treatment of vestibular disorders, which impact millions of Americans. Otolith’s patented non-invasive head-worn technology, which received Breakthrough Device Designation from the FDA for the treatment of chronic vertigo, uses precisely tuned vibrations to interact with the acceleration sensors in the inner ear, mitigating the symptoms of vertigo. 

Otolith is conducting clinical trials to evaluate its technology as an immediate symptom-relief treatment for chronic vertigo associated with vestibular disorders. The company recently announced results from an exploratory user study investigating the effect of vestibular stimulation on cybersickness from virtual reality (VR) experiences. The study demonstrated that subjects utilizing the Otolith technology had improved virtual environment experiences with lower reported nausea and longer VR durations. Review Founder & CEO Sam Owen’s LSI USA ‘23 presentation on the LSI website (Resources > Video Library).