ECG + PPG, the new gold standard

The wearables industry has evolved rapidly over the past decade. What began as simple fitness trackers has transformed into a health-tech frontier, where users are demanding real health insights, and clinicians are increasingly exploring how to leverage these tools to support patient care 1. This shift toward health-centric wearables comes at a critical time, as the burden of chronic conditions—particularly cardiovascular disease—continues to grow at an alarming pace.

• Heart disease could affect at least 60% of adults in U.S. by 2050 (skyrocketing to $1.85 trillion in costs). 2
• Atrial Fibrillation (AF) risk is three times higher than previously estimated, now affecting 10.5 million Americans. With an aging population, hypertension, and diabetes, cases are projected to reach 12.5 million by 2030. 3
• Nearly half of the U.S. population (48.6%) have some type of cardiovascular disease (CVD). 4

For wearable companies, this means opportunity—but also pressure. If your strategy relies solely on PPG (photoplethysmography) technology, you’re risking irrelevance. ECG (electrocardiogram) capability can become a critical lever for clinical credibility, user trust, and long-term growth. The global wearable healthcare market is expected to exceed $60 billion by 2028 5, with much of this growth driven by health-focused devices6.

Is PPG enough?

PPG is the optical heart sensor that uses LED lights paired with photodiodes to measure blood volume in a user’s wrist or finger. It is the cornerstone of most health wearables today. Compact and energy-efficient, it enables continuous monitoring of trends like heart rate, blood oxygen, or HRV. One of its health applications is the detection of pulse irregularities, a potential signal of underlying arrhythmias such as AF.

However, while PPG can flag irregular pulse patterns, it cannot determine the type of arrhythmia. This is a critical distinction.

AF, ectopy, or benign variability can all produce irregular pulse intervals, but the clinical response differs dramatically depending on the underlying cause, and PPG lacks the context to distinguish between them 7. PPG’s sensitivity to motion artifacts and ectopic beats can result in misclassifications leading to false positives 8, where the device flags an irregular pulse that isn’t real or clinically significant. These false alerts may cause users to experience unnecessary anxiety, prompting visits to healthcare professionals for reassurance or additional testing. Over time, this not only creates a burden on healthcare systems, but can also undermine trust in the device and the brand.

Pairing it with ECG addresses these gaps—enabling more precise rhythm classification and reducing unnecessary alerts.

Next-Gen Heart Monitoring

ECG the electrical activity of the heart directly. It has been the gold standard for detecting heart rhythm abnormalities for over a century, and it’s relied on by clinicians from primary care to cardiology. Wearable ECG implementations, typically single-lead, enable accurate AF classification 9 and open the door to clinical-grade market opportunities.

It’s no longer a choice between ECG and PPG. PPG has limited accuracy due to movement artifacts, whereas ECG cannot be used continuously in a watch or ring form factor and is limited in asymptomatic cases 10. Leading devices like the Apple Watch already combine both technologies 11 to deliver a more accurate and better user experience. Here’s why:

• PPG is ideal for continuous background monitoring as it provides a useful first line of screening to trigger further investigation.
• ECG is ideal for high-confidence rhythm analysis. Once the user receives an alert of a potential rhythm irregularity, the wearable requests the user to carry a 30 second spot-check to confirm or rule out an underlying arrhythmia.

A study published in Frontiers in Cardiovascular Medicine showed that the combination of both technologies provides higher specificity, or fewer false positives, than PPG or ECG alone.12 This highlights a key advantage of the combined approach: reducing false positives not only improves clinical confidence but also protects users from unnecessary worry and helps preserve brand trust.

New Market Opportunities

Combining ECG with PPG opens new markets and defends against competitive threats. Three main opportunities are unlocked when clinical-grade ECG is provided, and they all start with physician support:

• Physician recommendations to patients and loved ones.
• Open the opportunity to the B-to-B healthcare market with Payers, Clinical Research Organisations, and Employers.
• Gain access to reimbursed programs such as Remote Patient Monitoring, Transition Care Monitoring, Chronic Care Monitoring.

And unlike step counts or sleep scores, ECG is harder to commoditise. It requires regulatory oversight and higher validation efforts compared to simpler PPG-based features, raising the bar for accuracy and trust. This makes ECG a differentiator that adds lasting value, rather than a feature that can be easily copied or mass-produced.

What’s Holding You Back?

Companies might hesitate about adding ECG due to perceived barriers. Let’s break them down.

“Regulation is too complex.” Adding ECG for heart rhythm analysis brings regulatory requirements, such as ISO 13485 compliance and securing a 510(k) or CE Mark to sell your product in the US or European markets. However, partners like B-Secur can help you efficiently navigate this process. We have achieved two FDA 510(k) clearances on our own device agnostic ECG software products (K200884 and K233755) and have 5+ years of expertise helping consumer brands add ECG into their wearables.

“It’s too expensive or adds complexity.” ECG hardware design used to require multiple electronic components and extensive engineering. Today, highly integrated Analog Front Ends (AFEs), electrode evaluation kits and off-the-shelf algorithm solutions dramatically reduce time to market and cost. B-Secur offers products and professional services to help you achieve your wearable goals.

“Users don’t care.”. On the contrary—there is strong and growing consumer interest in heart health tracking. Our recent survey showed that users increasingly seek wearables not just for fitness, but for early warning signs and health and wellness management. The rise of ECG-enabled smartwatches from major brands has helped educate consumers about conditions like Atrial Fibrillation, while increased media coverage and awareness of heart health risks—especially in ageing populations—has fuelled demand.

The question isn’t whether to add ECG— It’s how quickly you can integrate it in a way that sets you apart.

At B-Secur, we help wearable companies integrate ECG with confidence regardless of the form factor and specific needs—from ECG signal chain design, to signal quality evaluation, pre-compliance testing, regulatory support, and 510(k) cleared ECG algorithms.

Whether you’re exploring feasibility or preparing a product launch, we can help shorten your path to market.

1. https://newsnetwork.mayoclinic.org/discussion/ai-transforms-smartwatch-ecg-signals-into-a-diagnostic-tool-for-heart-failure/

2. https://www.heart.org/en/news/2024/06/04/heart-disease-and-stroke-could-affect-at-least-60-percent-of-adults-in-us-by-2050

3. https://www.health.harvard.edu/mens-health/three-times-as-many-people-have-atrial-fibrillation-than-previously-known

4. https://newsroom.heart.org/news/more-than-half-of-u-s-adults-dont-know-heart-disease-is-leading-cause-of-death-despite-100-year-reign

5. Wearable Healthcare Devices Market worth $69.2 billion by 2028 https://www.marketsandmarkets.com/PressReleases/wearable-medical-device.asp?utm_source=chatgpt.com

6. Wearable Medical Devices Market Trends https://www.grandviewresearch.com/industry-analysis/wearable-medical-devices-market

7. Hemingway, J. et al. (2021). Photoplethysmography for the detection of atrial fibrillation: A systematic review and meta-analysis.* Australasian Physical & Engineering Sciences in Medicine, 44, 613–633. https://doi.org/10.1007/s13246-021-01072-5

8. https://afiponline.org/articles/weighing-the-effectiveness-of-photoplethysmography-signal-analysis-in-population-diagnosis-of-atrial-fibrillation

9. De Bie et al., 2021

10. https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.869730/full

11. https://www.apple.com/uk/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf

12. https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.869730/full