Wearable sensors (smartwatches, bands, patches, smart clothing, etc.) are central to device-based digital health. These devices continuously monitor vitals (heart rate, blood pressure, glucose, motion, etc.) and generate “digital biomarkers.” For example, sensor-based digital biomarkers enable remote health tracking in care and trials, and regulatory bodies in the U.S. and EU have even approved the first digital endpoints based on wearable data.¹ One market report noted 1.2 billion people globally owned a smartwatch by 2023,² reflecting mass consumer uptake of health wearables. Among U.S. adults, 35% already use some wearable health device.²

Why It Matters

The global digital health market has surged post-pandemic. One research organization estimated the digital health market at $289 billion in 2024, projecting growth to $946 billion by 2030 (22% CAGR).³ Wearable medical devices alone were worth $91.2 billion in 2024 and were forecast to reach $324.7 billion in 2032 (17.8% CAGR).² Growth is driven by aging populations and chronic diseases: for example, >500 million people currently live with diabetes—and that number is expected to rise to 1.3 billion in 30 years.² North America remains the largest market, but Asia Pacific is growing fastest, and Europe has become a hotbed of digital health innovation.^2,3

Wearable Sensors and Digital Biomarkers

Healthcare-specific wearables encompass everything from consumer activity trackers to medical-grade sensors. By product type, diagnostic and monitoring devices [like heart and continuous glucose monitors (CGM)] dominate the wearable market.² Technological advances in tiny accelerometers, gyroscopes, photoplethysmography (PPG), and sweat- or interstitial-fluid sensors have made continuous, non-invasive monitoring feasible. For example, advanced CGMs now use AI algorithms to not only measure glucose but also predict dangerous fluctuations hours in advance.⁴ Similarly, AI-enhanced cardiac wearables analyze ECG/PPG waveforms to detect subtle arrhythmias and predict potential cardiac events with high accuracy.

Wearables are also penetrating orthopedics and rehabilitation. In post-implant care (e.g., after knee/hip replacement), inertial sensors embedded in shoes, socks, or wearables can continuously measure gait and mobility. Early trials report that such wearables allow remote tracking of patient rehabilitation, improving adherence and enabling clinicians to detect complications earlier.⁵ One U.K. study noted wearable sensors can support “remote monitoring of patient rehabilitation in the outpatient setting, aiding adherence and early detection of complications”. Smart fabrics and in-shoe pressure sensors similarly enable daily gait analysis under real-world conditions,⁶ supporting personalized therapy and fall-risk assessment.

Remote Patient Monitoring

Remote patient monitoring (RPM) integrates wearables and home devices into care. Globally, the RPM market is growing rapidly. One analyst estimated $22 billion in revenue in 2024, rising to $110.7 billion by 2033 (nearly 20% CAGR).⁷ Adoption is skyrocketing: according to a Harvard Health Letter article, 50 million people in the U.S. are using an RPM device, and per an MSI International survey, 80% of Americans are in favor of using RPM technology.⁸ RPM programs target chronic conditions (diabetes, hypertension, heart failure, COPD, etc.), enabling care outside of hospitals. By continuously capturing vitals (BP, weight, glucose, ECG, SpO₂, etc.), RPM can reduce hospital readmissions and manage disease proactively.

Clinically, RPM is moving into mainstream pathways. For example, England’s NHS has launched “virtual wards” to monitor patients at home—freeing hospital beds while keeping close watch on high-risk patients.⁷ Remote monitoring platforms often combine multiple sensors with AI analytics, creating end-to-end solutions. One analysis noted that providers are now using integrated platforms—linking wearable data and symptom apps—to “detect recurrence and even predict future health changes” and fast-track safe discharges (hospital-at-home models).¹ Such platforms have also spurred new reimbursement pathways: U.S. and European regulators are adopting accelerated approvals and coverage for RPM tools. In the U.S. alone, recent years saw CMS expand coverage for RPM/RTM (remote patient or therapeutic monitoring) services, reflecting this trend.

Artificial Intelligence Integration

Artificial intelligence (AI) and machine learning (ML) are deeply embedded in modern digital health devices. From smartphone apps to hospital monitors, AI algorithms analyze the vast data streams from sensors and imaging to aid diagnosis and monitoring. The regulatory pipeline reflects this: by mid-2025, the FDA had cleared 1,250 AI/ML-enabled medical algorithms for clinical use. The vast majority were in imaging, but 116 were in cardiology.⁹ Dozens of AI-powered cardiac tools are approved. For instance, the AT-Patch by ATsen (a disposable ECG patch) and VitalConnect’s wearable patch both use FDA-cleared algorithms to identify arrhythmias in long-term ECG data.⁹ Even consumer wearables incorporate AI: the Fitbit “Loss of Pulse” app analyzes pulse waveforms to detect sudden pulselessness and automatically alert emergency services if needed.⁹

AI is also enabling new digital diagnostics. Today, there are over 100 commercial software devices that use sensor data and AI to screen or diagnose diseases.¹ For example, smartphone camera apps can screen diabetic retinopathy or skin cancer using ML; wearable seizure monitors use EEG and AI to detect epilepsy events; and novel tools claim to detect early signs of autism or sleep apnea via at-home sensors. In clinical trials, sensor-based digital endpoints—continuous physiologic measures captured via wearables—are gaining regulatory acceptance as study endpoints.¹ Overall, investment is going heavily into AI-based digital health: according to a recent CB Insights report, in Q1 2025, more than 60% of digital health VC funding went to AI-focused startups.¹⁰

Applications in Specialized Care

Orthopedics (Gait and Rehab)—In orthopedics, digital devices are increasingly used to monitor mobility and recovery. Smart gait-analysis wearables (shoe sensors, inertial IMUs, pressure-sensing insoles, or smart socks) can continuously measure stride, balance, and activity after joint replacement. Clinicians use this data to customize rehabilitation programs and identify problems early. For example, studies in knee arthroplasty patients have deployed accelerometer-based wearables to track range-of-motion and gait metrics. In one trial protocol, researchers noted, “wearable sensors have the potential to allow remote monitoring of patient rehabilitation…aiding adherence and allowing…early detection of complications.”⁵ Commercial products like smart insoles (e.g., Feetme) and wearable motion belts are now used in trials and pilot programs to quantify walking quality in post-arthroplasty care. These technologies extend care beyond the clinic, enabling surgeons and therapists to monitor progress and intervene remotely.

Cardiology—Digital health has long targeted heart disease. Today’s portfolio spans implanted devices (pacemakers/ICDs with telemetric follow-up) to consumer wearables. Continuous ECG monitors—from adhesive patch recorders (e.g., Zio by iRhythm or AT-Patch) to smartwatches—allow days/weeks of heart rhythm monitoring outside hospitals. Many use AI to flag arrhythmias (e.g., FDA-cleared software like Volta Medical’s AF-Xplorer helps electrophysiologists annotate atrial fibrillation in 3D heart maps, while VitalConnect’s VitalRhythm AI continuously scans outpatient telemetry for dangerous arrhythmias).⁹ Consumer platforms (Apple Watch, Samsung, Fitbit) now include ECG/PPG-based AFib screening; notably, the Fitbit “Loss of Pulse” app is FDA-regulated to warn wearers of pulselessness.⁹

Beyond rhythm, AI is enhancing cardiac imaging and diagnostics. Hundreds of AI-cleared algorithms (CT calcium scoring, echo analysis, cardiac MRI) are in clinical use. Cardiology ranks second only to radiology in AI tool volume.⁹ Remote cardiac rehab platforms are emerging too: patients recovering from heart procedures can use connected devices (BP cuffs, activity trackers, ECG patches) plus coaching apps to continue rehab at home, sometimes under cardiologist oversight via telemonitoring.

The Medi-Vantage Perspective

There are so many more applications by medical specialty. In 2025, nearly every medical specialty will have specifically tailored digital health applications. For orthopedics, gait sensors guide rehab; in cardiology, wearables and AI analyze ECG data; in diabetes, connected sensors and apps manage glucose. Other fields (pulmonology, neurology, oncology, etc.) are also adopting digital measures (e.g., home spirometers for COPD, neuro rehab apps). This convergence of devices, AI, and remote platforms is reshaping patient care across the board. Ensure your devices have a digital component or accessory, and if they don’t, it is time to research to find out how to design your companion digital health device (preferably specialized) that drives the adoption of your device.

References

1. tinyurl.com/mpo251101
2. tinyurl.com/mpo251102
3. tinyurl.com/mpo251103
4. tinyurl.com/mpo251104
5. tinyurl.com/mpo251105
6. tinyurl.com/mpo251106
7. tinyurl.com/mpo251107
8. tinyurl.com/mpo251108
9. tinyurl.com/mpo251109
10. tinyurl.com/mpo251110

MORE FROM THIS AUTHOR—Surgical Robotics in 2025: What Medtech Leaders Need to Know

Maria Shepherd has more than 20 years of experience in marketing in small startups and top-tier companies. She founded Medi-Vantage, which provides marketing and business strategy for the medtech industry. She can be reached at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.