Wearables, Healthcare and Reimbursement: Why Medical-Grade ECG is Unlocking the Next Growth Market

CMS payment models are aligning around prevention and continuous monitoring, turning clinical trust into a new competitive battleground for wearable brands.

For years, wearables have promised to support prevention and remote care. Step counts, heart rate trends and recovery scores helped normalise continuous monitoring and proved that consumers will engage with health data daily, not only when they are unwell. It pointed to a future where health could be managed proactively and outside the clinic.

The problem has never been the technology itself, but the payment system. Healthcare reimbursement was not built to reward prevention, early detection or keeping people well at home. Put simply, what wearables enabled, the system had no consistent way to pay for.

That is now starting to change.

In late 2025, CMS made a decisive shift. It moved beyond small, voluntary pilots and introduced longer-running, technology-enabled models designed to reward outcomes such as reduced hospital admissions, better chronic disease control, and sustained engagement outside the clinic.

In effect, CMS is rewiring incentives so reimbursement starts to favour exactly what clinically credible wearables can deliver. Providers are now financially incentivised to keep patients stable, supported and monitored at home, and wearables are one of the most scalable ways to do that.

That is why, at B-Secur, we see healthcare as the next growth frontier for wearables, and why medical-grade signals, including ECG, are shifting from “nice to have” to commercially essential.

The turning point: from pilot programmes to payment infrastructure

For more than a decade, Medicare tested value-based care through the Center for Medicare and Medicaid Innovation (CMMI). These programmes proved that care could be delivered differently, but they also revealed a hard truth: Innovation without predictable reimbursement does not scale.

Health systems may pilot novel approaches. Clinicians may show interest. But without durable payment models, adoption stalls.

That is why the final months of 2025 matter.

In a short period, CMS announced multiple new models focused on chronic disease management, specialty accountability, and technology-enabled delivery. More importantly, the underlying philosophy changed with CMS moving away from cautious experimentation towards building long-term payment infrastructure, formalised in the CMS Innovation Center’s updated 2025 Strategic Direction.

The message to the market is unambiguous. Reimbursement is no longer a series of pilots. It’s becoming part of the operating system.

For wearable manufacturers, 2025 marks the moment healthcare shifts from next to now and becomes a tangible growth market.

Why the reimbursement shift makes wearables commercially inevitable

Healthcare adoption follows incentives. When providers are paid for visits and procedures, there’s little financial reason to monitor patients continuously or intervene early. But when payment is tied to outcomes, the incentives flip. Preventing deterioration becomes valuable. Keeping patients stable at home becomes the goal.

To make that work, clinicians need continuous, reliable signals they can trust.

That is exactly the environment value-based care is designed to create.

CMS’s late-2025 strategy reinforces three shifts that matter directly for wearables:

1. Longer horizons create investment certainty

Ten-year models fundamentally change behaviour. They justify investment in technology, workflow integration, and long-term partnerships. They also remove the “wait and see” hesitation that short pilots encourage.

2. Technology is no longer optional

Wearables and remote monitoring are moving from experimental add-ons to serious, core components of prevention and care delivery.

3. Outcomes, not activity, drive payment

Providers are rewarded for reducing admissions, managing chronic disease, and sustaining engagement. That aligns directly with what clinically credible wearables can deliver.

In short, reimbursement is being redesigned around prevention, and wearables are one of the most scalable ways to deliver it.

The opportunity is bigger than most wearable strategies assume

The conditions targeted by these models are not niche. They include cardiovascular disease, hypertension, diabetes, kidney disease, obesity, behavioural health and cancer, exactly the long-term conditions that drive the greatest burden in the Medicare population and become more common with age.

This also connects directly to the opportunity highlighted in our earlier blog. The 55+ demographic holds the majority of wealth and has the highest willingness to pay for health insight they can trust.

Performance tools win attention. Preventive tools win longevity, and reimbursement is starting to reward that shift. The most valuable wearables are no longer those optimised for performance. They are the ones that support long-term condition management, early risk detection and sustained engagement for ageing populations.

This is the bridge between consumer adoption and healthcare scale. The consumer market is attractive. Reimbursement makes it durable.

From consumer adoption to healthcare adoption: what changes in practice

Entering healthcare does not mean replacing clinicians. It means fitting into their workflow.

That requires:

• signals clinicians can trust
• data that is interpretable, not just abundant
• integration into remote monitoring pathways
• alignment with reimbursement models
• regulatory readiness

This is where many consumer wearables can stall. Not because users abandon them, but because healthcare operates under different rules where clinical trust and reimbursement alignment are the real differentiators.

The implication is simple. As reimbursement accelerates adoption, the devices that meet clinical expectations gain value, and the ones that do not hit a hard ceiling.

Why medical-grade ECG sits at the centre of this shift

ECG is not new, but its role in wearables is changing fast. As healthcare starts paying for prevention and continuous monitoring, the question is no longer whether a device can capture a signal, but whether that signal stands up in the real world.

Many devices can capture an ECG waveform. Far fewer can deliver medical-grade ECG analysis that remains reliable when motion artefact, inconsistent skin contact and everyday noise are unavoidable.

For clinicians and reimbursement pathways, that distinction is decisive.

When payment models reward early intervention and chronic risk management, providers need signals they recognise, interpret and act on. Clinically robust ECG meets that requirement, delivering insight that becomes increasingly valuable as cardiovascular risk rises with age.

For manufacturers, this changes product economics. Medical-grade ECG stops being a feature and becomes a route into healthcare. It is what takes a wearable from a discretionary lifestyle product into a device that can participate in reimbursed pathways.

As reimbursement scales, demand will concentrate around wearables that deliver clinically credible physiology, not approximations.

Regulation is clarifying the line and reimbursement is rewarding those who cross it

In early 2026, the FDA signalled it would limit regulation of low-risk wellness wearables, while maintaining scrutiny for devices making medical-grade claims. The line is becoming clearer: wellness tools can move fast, but medical tools must stand up to clinical scrutiny.

For wearable manufacturers, that creates a narrow strategic window. Those who build clinical credibility now can scale as reimbursement-backed demand grows, while those who wait risk playing catch-up once healthcare partnerships and care pathways are already established.

This matters because reimbursement is changing how enterprise value is created in wearables. Historically, devices have been valued like consumer products, driven by subscriptions, retention and lifestyle market share. As wearables enter reimbursed pathways, value increasingly comes from durable healthcare distribution, multi-year provider relationships and access to larger, stickier revenue pools that are not available in the wellness category.

Not every reimbursement model requires full FDA clearance from day one. Programmes such as TEMPO explicitly allow certain non-cleared devices to participate while real-world evidence is generated. However, as devices become embedded in clinical decision-making and scaled across health systems, expectations around validation, reliability and regulatory readiness rise quickly. Over time, the wearables that sustain reimbursement-backed growth will be those that can meet clinical standards consistently.

HeartKey® Core: clinical-grade ECG that accelerates healthcare entry

For consumer wearable manufacturers, the opportunity is clear, but the path is complex. Building medical-grade ECG capabilities from the ground up is costly, time-consuming and uncertain. It requires specialist signal processing expertise, clinical validation and regulatory understanding, all of which sit outside the core strengths of many consumer brands.

HeartKey® Core provides a direct route. It is an FDA-cleared ECG analysis solution designed to enable wearable devices to deliver clinical-grade ECG in real-world conditions, where motion, noise and inconsistent skin contact routinely degrade signal quality.

For manufacturers, this translates into three strategic advantages.

1. Clinical credibility

FDA-cleared ECG positions a wearable as a device clinicians and users can trust for health decision-making, not just tracking.

2. Faster healthcare entry

A proven ECG solution reduces development time and regulatory risk, allowing manufacturers to enter healthcare markets without rebuilding capabilities from scratch.

3. Access to larger, higher-value markets

Medical-grade ECG opens the door to healthcare partnerships and reimbursement-aligned pathways that are not accessible to wellness-only devices.

The next five years are the adoption window

Value-based care is entering a new phase, defined by larger programmes, longer time horizons, technology-first design and outcome-aligned payment.

This shift will shape procurement decisions, partnership models and infrastructure investment across US healthcare over the next five years. Wearables are already part of that future. The question is which brands will become trusted tools within it.

Looking ahead

Wellness helped wearables reach scale. Healthcare will determine who grows next.

Clinical trust is now a business requirement. With cardiovascular disease remaining the biggest cause of death globally and projected to increase substantially over the next decade through to 2050, medical-grade ECG is becoming a gateway capability. It enables healthcare entry, supports reimbursement alignment and underpins access to the next growth market for wearables.

The race is no longer about who has the most engaging dashboard. It is about who can become clinically credible first.