Apple has faced a persistent regulatory and legal hurdle in the United States over its latest Apple Watch models, forced to reconsider how it delivers health features in the midst of a patent dispute. After being blocked from selling the Apple Watch Series 9 and Ultra 2 in the U.S. due to a dispute over pulse oximetry technology, Apple devised a software-based workaround to bring the devices back to market. By disabling the blood oxygen feature rather than redesigning the hardware, Apple aimed to comply with the court’s rulings while still offering the devices to a U.S. audience. This drift between hardware capabilities and software controls has raised questions about the durability of the workaround, the long-term viability of the current strategy, and what it means for users who purchased or plan to purchase Series 9 and Ultra 2 devices in the United States. The situation remains fluid as legal maneuvers unfold and as Apple continues to navigate regulatory constraints while Masimo maintains its own public stance around the technology at the center of the dispute.
Background: the legal backdrop that led to the US sales ban
The friction between Apple and Masimo began long before the current iteration of the Apple Watch was introduced to the market. In January 2023 a U.S. court ruled that Apple had infringed one of Masimo’s patents related to pulse oximetry technology, a sensor-based capability that estimates blood oxygen levels. This ruling marked a pivotal moment because pulse oximetry is a core feature that adds a health-monitoring capability to smartwatches and other wearable devices. The court’s decision established a foundation for further actions in related proceedings and set the stage for higher authorities to weigh in on the matter.
Subsequently, in October 2023, the United States International Trade Commission (ITC) affirmed the court’s finding of infringement. The ITC’s concurrence reinforced the conclusion that Apple’s implementation of pulse oximetry in its watches violated Masimo’s intellectual property. The combined impact of these rulings created a tangible consequence for Apple: the temporary prohibition on the sale of Apple Watch Series 9 and Ultra 2 in the United States. This ban interrupted a key product line and forced Apple to reevaluate how it could offer health features that rely on the same sensor technology at the heart of the dispute.
The ban was not a straightforward halt that could simply be circumvented by minor adjustments. Initially, Apple sought relief through the appeals process, arguing that the decision should be reviewed and possibly overturned by a higher court. This legal pathway is common in patent disputes where large-scale consumer electronics are involved, given the complexities of technology patents and the broad implications for product lines. However, the appellate route did not yield the outcome Apple hoped for in the timeframe that mattered for product launches and consumer access. The overarching effect was a pause in US sales that could only be resolved through alternative means, whether through settlement, further legal remedies, or a functional adjustment to the product’s health features.
In this context, Apple faced a choice: either pursue a redesign that would alter or remove the contested feature, or devise a solution that could legally sidestep the core issue without sacrificing the broader value proposition of the watch. The company ultimately pursued the latter by focusing on software-enabled adjustments rather than hardware changes. This decision reflected a strategic balance between continuing to offer devices to U.S. customers, preserving the core functionalities that do not rely on the contested technology, and remaining compliant with the legal constraints imposed by Masimo’s patents. What followed was a careful orchestration of software updates and official communications designed to align the product’s capabilities with the regulatory environment while minimizing disruption to users and preserving the brand’s market position.
The sequence of rulings and regulatory actions intensified the scrutiny around how health sensors operate in wearables and whether software can be used to selectively enable or disable features across different regions or product variants. The Masimo–Apple dispute thus became a focal point for broader questions about intellectual property, sensor technology, and the governance of health features in consumer devices. This backdrop framed Apple’s subsequent actions: a measured approach to feature delivery, a consideration of regional restrictions, and a willingness to make technical concessions to keep the devices available in the U.S. market. As the story evolved, the core issue remained the same: a tension between patent rights and the practical needs of a global consumer electronics business that seeks to deliver health features that users expect as standard in premium wearables.
The workaround emerged: disabling Blood Oxygen through software
Facing regulatory pressure and the need to maintain market access, Apple implemented a software-based solution designed to remove the contested health feature from its devices sold in the U.S. market. The practical effect of this strategy was straightforward: the devices would no longer provide the pulse oximetry function—an essential health metric—while still retaining other capabilities that define the Apple Watch’s health and wellness ecosystem. Apple publicly indicated that the Series 9 and Ultra 2 would be updated to exclude the Blood Oxygen feature, marking a clear delineation between hardware capabilities and software-controlled features. The company’s public-facing statements referenced a version of the watches that no longer included blood oxygen monitoring, signaling a targeted adjustment rather than a wholesale hardware revamp.
A critical detail surrounding this approach involved the identification of the revised device variants. The updated models were observed to carry part numbers ending in “LW/A,” a pattern that suggested a specific regional or configuration variant. This naming convention appeared to reflect a deliberate software-access control tied to the device’s regional provisioning and feature entitlement. In other words, these “LW/A” devices were designed to operate with the Blood Oxygen sensor disabled in the United States, even though the underlying hardware remained capable of supporting the feature in other markets or in the event of a future software change. This distinction between hardware capability and software-enabled functionality became a central talking point in discussions about the true nature of the update and the potential for reversibility.
Behind the scenes, a more nuanced technical mechanism was at play. The update involved a remote system file that governs how health features are made available by region. By modifying this file, Apple could effectively turn off the blood oxygen functionality for devices classified under the LW/A designation. The important implication here is that the disabling was not a manual toggle for end users but a centralized configuration managed by Apple’s servers and device identifiers. This arrangement allowed Apple to enforce compliance with the court’s rulings while maintaining the broader hardware platform’s integrity. It also introduced a path for future reversals if the legal climate shifted or if a favorable ruling emerged in subsequent proceedings.
The timing of the software update adds another layer of significance. The component responsible for blocking the pulse oximeter feature was uploaded to Apple’s servers in October 2023—the same month the ITC upheld the judge’s ruling. This coincidence underscored the company’s preparedness and willingness to act decisively when regulatory outcomes demanded a rapid response. By having a remotely deployable file ready to govern health features by region, Apple signaled that it anticipated the need for a controlled and scalable approach to feature availability. The readiness of this update suggested that Apple expected the dispute to persist and that the company preferred a software-centric solution rather than a more disruptive hardware revision, given the potential costs and complexities of a wholesale hardware redesign and re-certification process.
From a user experience perspective, the software-based approach had the advantage of preserving the watch’s core form factor, battery life, and software ecosystem while removing a high-profile health feature that was central to Masimo’s patent contention. For Apple, the strategy aimed to maintain distribution velocity in the U.S. market and to avoid a scenario in which competitive pressure could erode consumer confidence during an ongoing legal battle. It also provided Apple with a degree of flexibility: if the legal landscape shifted, Apple could, in theory, reverse the disablement by adjusting the system file or re-validating the feature for the LW/A models, thereby restoring blood oxygen monitoring in the future.
In practice, this means that the “new” Series 9 and Ultra 2 models sold in the United States were, at the software layer, configured to operate without the blood oxygen sensor. The hardware remained capable, but the software gating rendered the feature inactive for protected regions and model variants. This distinction between what the hardware could do and what the software allows it to do became a central point in discussions about product engineering, regulatory compliance, and consumer rights. The net effect for users was that blood oxygen data would no longer be available on these devices in the U.S. under the LW/A configuration, even if the same hardware might enable the feature in other regions or under a different software entitlement.
Hardware vs software: did Apple actually ship new hardware without the sensor?
A natural question arising from the software-driven approach is whether Apple was shipping entirely new hardware that lacked a functioning blood oxygen sensor, or whether the devices were the same hardware with a software gate applied to disable the feature in the United States. The evidence gathered from observers and subsequent investigations suggested that Apple did not remove or physically alter the pulse oximeter hardware. Instead, the approach appeared to rely on a software gating mechanism that could be activated or deactivated remotely, based on model identifiers and regional entitlements. This interpretation aligns with Apple’s broader strategy of using software controls to tailor product capabilities without necessitating a physical redesign for every market or regulatory scenario.
The remote file that governs the availability of health features by region effectively serves as a feature flag system. When set to disabled in LW/A variants for the U.S., the pulse oximeter would not be accessible to users, even though the hardware is technically capable of performing the measurement. This mechanism has several important implications. First, it preserves a degree of product consistency across markets, as the same hardware and software stack can be deployed globally, with feature access controlled by server-managed configuration. Second, it provides Apple with a degree of agility: if the legal or regulatory environment changes, Apple could alter the configuration to re-enable the feature in the same devices without a new device rollout. Third, it raises questions about user expectations and transparency: customers may assume that a feature is accessible if the hardware exists, and software gating can complicate the perception of what the device is capable of doing out of the box.
Another facet of the hardware-versus-software question concerns future reversibility. The October 2023 file upload, which enabled the gating for LW/A models, indicates a deliberate, time-stamped change that could hypothetically be reversed if regulatory conditions became favorable or if a settlement or court ruling permitted a broader use of Masimo’s patented technology. In other words, Apple’s readiness to disable the feature by region suggests a built-in mechanism for reinstatement, potentially through an updated system file or reconfiguration of the entitlement. This reversibility is critical for stakeholders who wonder whether the practical limitations imposed by the current configuration are permanent or temporary. It remains to be seen how the legal process evolves and whether any future decision would necessitate a broader or permanent solution that would require reintroducing blood oxygen monitoring across all LW/A models in the U.S.
From a consumer protection and market strategy perspective, the distinction between hardware and software gating matters. If Apple can reliably re-enable the feature in a region or for specific models, customers who were initially deprived of a core health metric might benefit from a future software update that restores functionality. Conversely, if the gating becomes entrenched due to a durable settlement, customers could face a longer-term limitation that is not a matter of hardware capability but of regulatory compliance. In either case, the ongoing legal dispute acts as a dynamic backdrop that informs Apple’s product lifecycle decisions, including how it markets health features and how it communicates about feature availability to the public.
Impacts on users, retailers, and the broader market
The immediate practical impact of the software-based disablement is felt by a subset of Apple Watch purchasers in the United States who were considering or had already acquired Series 9 or Ultra 2 devices. For new models sold in the U.S., the Blood Oxygen feature is not available, as indicated by the updated product positioning and feature lists associated with the LW/A variants. This creates a clear, measurable difference in user experience compared to versions of the watches sold in other regions or under other configurations where blood oxygen monitoring remains accessible. The absence of this feature in the U.S. reduces the total health-tracking capabilities that the Apple Watch brand has previously marketed as a comprehensive health tool, which could influence purchasing decisions for health-conscious consumers who rely on pulse oximetry as part of their daily wellness monitoring.
For existing owners who already possessed a device prior to the updated configuration, the current approach suggests there would be no immediate plan to impose new restrictions or to invalidate features on devices already in use. The policy appears to apply to new units being sold in the U.S. market, which means current owners could maintain access to Blood Oxygen functionality if their devices are not subject to the LW/A regional gating. This nuance is relevant for consumer trust and for the secondary market, where the perception of a feature’s availability can influence resale values and buyer confidence. It also emphasizes the role of regional policy in shaping the user experience, highlighting how global tech ecosystems must adapt to legally binding restrictions in different jurisdictions.
Retail channels and marketing messaging will likely reflect the updated reality. Stores and online listings may clearly state that Blood Oxygen monitoring is not available on the U.S.-sold LW/A models, while versions intended for other markets or configurations could still include the feature. The clarity of such messaging is important for consumer expectations and for avoiding confusion around what the device can do in a given market. The broader market implications extend beyond Apple’s own ecosystem. Competitors that offer health-sensor-equipped wearables may observe customer reactions and regulatory responses, which could influence product development strategies, feature prioritization, and regional market strategy across the wearables segment.
From a health-data perspective, the change raises questions about user reliance on pulse oximetry data from smartwatches. Pulse oximetry has become a common metric in consumer health tools, offering insights into oxygen saturation and related conditions. The temporary or software-based reduction of access to this data in the U.S. market could affect how users manage certain health scenarios, including monitoring during sleep, exercise, or respiratory health checks. Users who depend on real-time oxygen saturation readings for medical considerations may need to adjust their routines or seek alternative devices or clinical-grade tools to maintain continuous monitoring. While the practical health impact depends on individual use cases, the absence of a widely accessible blood oxygen feature on a flagship model in a key market invites users to reassess the balance between consumer devices and medical-grade equipment for ongoing health management.
From Apple’s perspective, the strategy serves multiple purposes. It helps the company maintain distribution momentum in the United States, a critical market for its ecosystem and services, without engaging in a costly hardware overhaul or a protracted re-certification process that could delay shipments. It also preserves the option to reverse the configuration if the legal situation changes, providing a flexible path to adapt to regulatory shifts without requiring a return to the factory or a complex supplier negotiation. The approach signals a principled, law-abiding stance that aligns product features with the results of patent litigation, even as it creates a nuanced experience for U.S. consumers. The long-term success of this strategy depends on how effectively Apple can convey the rationale to customers, manage expectations, and swiftly adjust when regulatory or legal outcomes warrant reintroduction of the feature.
The ongoing legal path and potential market implications
Apple’s conflict with Masimo is far from resolved, and the dispute is set against a backdrop of extended legal proceedings and regulatory considerations. Apple has previously indicated that the appeals process could extend well beyond a single year, highlighting the protracted nature of patent litigation in the technology sector. In this context, the current software-based workaround represents a temporary accommodation that allows Apple to continue offering its watches in the U.S. market while the legal process advances. The duration of the appeals pathway and any subsequent rulings will significantly influence whether the current gating remains in place, is adjusted, or—potentially—revised in a manner that restores full functionality to the affected models.
One crucial implication of the ongoing dispute is the potential for strategic settlement discussions or regulatory compromises that might realign feature access with the evolving state of Masimo’s patents. If a settlement materializes, Apple could potentially re-enable blood oxygen monitoring across LW/A models or pursue an alternative licensing agreement that would permit broader use of Masimo’s pulse oximetry technology in its Apple Watch lineup. Conversely, if the legal outcome leans in Masimo’s favor, Apple could face more stringent limitations or additional licensing requirements that would affect product design, cost, and user experience. The outcomes of the legal process will also likely influence the broader wearables market. Companies may reassess their own health-sensor implementations in light of patent enforcement trends, and regulatory bodies could scrutinize how software controls are used to govern health features across devices and markets.
The strategic dynamics of the Masimo–Apple dispute also intersect with consumer trust and brand perception. Apple’s decision to mask a core health feature behind a software configuration highlights how patent litigation can directly impact the feature set available to consumers. While the company has defended its approach as necessary to remain compliant and to minimize disruption, observers will watch closely how Apple communicates these changes and how the market responds to the perception of restricted functionality in flagship devices. Masimo, on its side, has consistently positioned the pulse oximetry technology as a crucial element of its patent portfolio and has framed the issue as one of protecting intellectual property and encouraging fair licensing practices. The collaboration, tension, and negotiations between these two major players in the health-tech space will continue to shape the policy landscape, influence consumer expectations, and shape the competitive dynamics in the wearable devices market.
In the broader context of health data and consumer electronics, the case serves as a reminder of the delicate balance between innovation, intellectual property rights, and public health considerations. Advancements in sensor technologies have the potential to unlock new capabilities for monitoring and managing health, but they also introduce complexities around licensing, regional restrictions, and the ethical implications of access to health metrics. As regulators, manufacturers, and healthcare stakeholders watch the Masimo–Apple dispute unfold, there is a push to define clearer pathways for how advanced health features can be offered across global markets while respecting intellectual property protections and ensuring patient safety and data integrity. The outcome could set a precedent for similar disputes involving other health sensors in wearable devices, influencing how features are rolled out, restricted, or licensed in the years ahead.
Looking ahead: what comes next for users and the industry
With the dispute continuing and potential rulings still pending, several plausible trajectories could shape the near to medium term for Apple Watch users, developers, and the broader wearables ecosystem. First, the appeals process could result in retention of current rulings or a shift in the legal posture that would allow broader use of pulse oximetry technology under licensure terms or revised patent interpretations. If a settlement or licensing agreement emerges, Apple might reintroduce blood oxygen monitoring across LW/A models in the United States, possibly with terms that reflect the negotiated rights and any adjustments to how the feature is marketed and documented. This would likely require coordinated updates to software, documentation, and possibly the hardware’s secure elements to accommodate any licensing constraints, but could restore the full health-tracking experience for many users.
Second, Apple could maintain the current gating as a long-term solution if the legal environment remains unfavorable or if licensing remains out of reach. In such a scenario, the company could continue to provide a robust health-tracking experience that emphasizes other sensors and metrics while keeping blood oxygen monitoring restricted by region or model variant. In this path, Apple would need to maintain transparent communications with users, clearly delineating which features are available in which markets, and ensuring that users in regions where blood oxygen is unavailable understand the limitation and the rationale behind it. The company would also need to address the potential implications for health outcomes, user trust, and comparative advantages against competitors that may offer full sensor capabilities in similar devices.
Third, the industry could see a shift toward new sensor technologies or licensing approaches that reduce dependence on a single patent position. If Masimo’s patents continue to be a central barrier, other manufacturers might pursue alternative sensing methods or pursue independent innovations that do not rely on the disputed technology. This could help diversify the market and reduce the risk of similar access limitations impacting other devices in the future. At the same time, regulatory bodies could seek to impose clearer standards for sensor-based health features, ensuring that patient safety and data accuracy are prioritized while respecting intellectual property rights. The net effect could be a more nuanced regulatory framework that balances innovation with enforceable rights, potentially encouraging more collaborative licensing arrangements rather than protracted litigation.
For consumers and healthcare enthusiasts, the ongoing developments will continue to shape expectations around wearable health features. Many users will be watching to see whether the Blood Oxygen functionality is reinstated, whether alternative solutions emerge, or whether new devices from Apple or competitors offer different approaches to pulse oximetry that avoid patent entanglements. The evolving situation also highlights the importance of staying informed about regional differences in feature availability and the ways in which software can gate hardware capabilities. As manufacturers test the limits of what hardware can do and how software policies can govern use, users may need to adapt their health-monitoring practices to align with changing device capabilities and regulatory realities.
Conclusion
The Apple Masimo dispute has pushed Apple to navigate a complex landscape where legal rulings, regulatory constraints, and product strategy intersect. By opting to disable the Blood Oxygen feature through a software-controlled mechanism for U.S.-market LW/A models, Apple demonstrated a willingness to maintain market access while honoring the constraints imposed by patent law. This approach preserves the device’s core hardware platform and broad health- and wellness-oriented ecosystem, even as a central feature remains temporarily inaccessible in a key market. The long-term outcome hinges on the evolution of the legal process, potential settlements, or licensing arrangements that could re-enable blood oxygen monitoring and harmonize regional feature access. In the meantime, Apple’s strategy illustrates how software governance can be used to adapt flagship devices to legal realities without triggering costly hardware redesigns, while Masimo continues to defend its intellectual property and its role in shaping the future of health sensing in wearables. The next phase will reveal whether the current configuration remains a durable solution or evolves into a gateway for broader feature restoration, licensing, or new industry patterns in how health data is delivered to consumers through wearable technology.
