Apple Secures Major Victory as ITC Declines Review, Upholding Redesigned Apple Watch Blood Oxygen Feature

Apple has achieved a significant legal triumph in its protracted patent dispute with Masimo over the blood oxygen monitoring capabilities of the Apple Watch, as the International Trade Commission (ITC) officially declined to review an earlier ruling that found Apple’s redesigned feature does not infringe Masimo’s patents. This decision effectively closes a critical chapter in a high-stakes legal battle, ensuring the continued availability of a key health feature on Apple’s popular wearable devices in the United States and affirming the tech giant’s innovative efforts to navigate complex intellectual property challenges.

The Heart of the Dispute: Blood Oxygen Sensing Technology

At the core of this multi-year legal saga lies the sophisticated technology enabling blood oxygen saturation (SpO2) measurement on the Apple Watch. Masimo, a medical technology company specializing in non-invasive patient monitoring, initiated legal action, alleging that Apple had infringed on several of its patents related to pulse oximetry, the method used to determine blood oxygen levels. Pulse oximetry works by emitting red and infrared light through the skin and measuring the light absorption by the blood, allowing the device to calculate the percentage of hemoglobin carrying oxygen. This feature, introduced with the Apple Watch Series 6 in 2020, rapidly became a cornerstone of Apple’s expanding health and wellness ecosystem, providing users with insights into their respiratory and cardiovascular health, particularly during sleep or at high altitudes.

Masimo contended that Apple not only stole its trade secrets but also poached key employees with intimate knowledge of its proprietary technology, specifically alleging infringement of patents covering various aspects of accurate SpO2 measurement, particularly in challenging conditions like motion or low perfusion. These patents are critical for medical-grade devices, and Masimo sought to protect its intellectual property, arguing that Apple’s consumer-grade implementation leveraged innovations developed over decades by the medical technology firm. For Masimo, a company built on innovation in patient monitoring, the lawsuit was a vital defense of its market position and technological leadership against a formidable new entrant in the health tech space.

A Chronology of Legal Confrontation

The legal battle between Apple and Masimo officially commenced in 2020, when Masimo first filed a lawsuit accusing Apple of patent infringement and trade secret misappropriation. This initial filing marked the beginning of what would become a complex and closely watched legal struggle spanning multiple jurisdictions and legal bodies.

In June 2021, Masimo escalated its offensive by filing a complaint with the U.S. International Trade Commission (ITC), an independent quasi-judicial federal agency that investigates alleged unfair practices in import trade, particularly patent and trademark infringement. The ITC is empowered to issue exclusion orders, effectively banning the import and sale of infringing products in the U.S. This move was a strategic escalation, as an ITC ruling could lead to a swift and impactful ban on Apple Watch sales.

After a thorough investigation, an ITC administrative law judge (ALJ) issued a preliminary ruling in January 2023, finding that Apple had indeed infringed on certain Masimo patents. This finding was subsequently affirmed by the full ITC in October 2023, which recommended an import ban on Apple Watch models containing the infringing blood oxygen feature. The decision sent shockwaves through the tech industry, highlighting the serious implications of patent disputes for even the largest corporations.

Following the ITC’s final determination, a 60-day presidential review period ensued, during which President Joe Biden’s administration could veto the import ban. However, on December 26, 2023, the Biden administration chose not to overturn the ITC’s decision, allowing the import ban to take effect. This forced Apple to halt sales of its Apple Watch Series 9 and Apple Watch Ultra 2 models in the U.S. just before the crucial holiday shopping season, a significant commercial blow. The temporary ban underscored the power of the ITC and the seriousness of patent infringement findings.

In response to the sales halt, Apple swiftly implemented a "redesigned" version of the blood oxygen feature. This redesign, which Apple developed to circumvent the patent infringement, involved modifying the software algorithms and shifting more of the data processing related to SpO2 measurement from the Watch hardware to the paired iPhone. The company argued that these changes rendered the feature non-infringing. By late December 2023 and early January 2024, Apple was allowed to resume sales of the modified Apple Watch models in the U.S. after U.S. Customs and Border Protection (CBP) approved the redesign.

Naturally, Masimo vehemently disagreed with this assessment, arguing that the redesigned feature still fell within the scope of the existing exclusion order and continued to infringe its patents. Masimo promptly filed petitions challenging the CBP’s approval and seeking to reinstate the ban. This led to a new enforcement proceeding at the ITC, focused specifically on whether Apple’s updated technology successfully "designed around" Masimo’s intellectual property.

Apple’s Redesign and the Path to Reinstatement

Apple’s strategy to circumvent the import ban centered on a clever re-engineering of its blood oxygen monitoring system. Instead of merely tweaking the hardware, which would have required extensive retooling and supply chain disruption, Apple focused on software modifications. The core of the redesign involved changing how the raw data collected by the Watch’s optical sensor was processed and interpreted. While the physical sensors remained largely the same, the algorithms that convert light absorption data into a blood oxygen percentage were altered, with a greater portion of the computational workload reportedly shifted to the paired iPhone.

The technical argument presented by Apple to the ITC and U.S. Customs and Border Protection was that by relocating specific processing steps and altering certain algorithmic approaches, the redesigned feature no longer utilized the patented methods claimed by Masimo. This subtle but significant shift in the data pipeline was enough to convince the authorities that the new implementation did not infringe. The approval by U.S. Customs and Border Protection in early 2024 was a critical first step, allowing Apple to resume sales, but Masimo’s immediate challenge meant the battle was far from over.

Masimo’s counter-argument was that these changes were superficial and that the essence of the patented technology, particularly related to signal processing for accurate readings, remained present in Apple’s updated design. They asserted that the redesigned watches still fell under the ambit of the existing limited exclusion order (LEO), which prohibited the import of infringing devices. However, on March 18, 2026, Administrative Law Judge (ALJ) Monica Bhattacharyya issued an enforcement initial determination (EID), concluding that the redesigned products did not infringe the asserted claims of Masimo’s patents. This was a pivotal ruling, validating Apple’s redesign efforts. Masimo promptly filed a petition for the full ITC Commission to review the ALJ’s finding, keeping the threat of a renewed ban alive until the final decision.

The ITC’s Definitive Ruling

Today’s decision by the full International Trade Commission marks a definitive turning point in the legal saga. The ITC formally declined to review the Administrative Law Judge’s (ALJ) enforcement initial determination (EID) issued on March 18, 2026. This means the Commission upheld the ALJ’s finding that Apple’s redesigned Apple Watch models, equipped with the modified blood oxygen feature, do not infringe Masimo’s patents.

The official statement from the ITC clarified the termination of the combined proceeding: "The Commission has determined not to review the EID. This combined proceeding is hereby terminated in its entirety with the conclusion that the accused redesigned products do not infringe the Asserted Patents, and therefore, they should not be excluded pursuant to the terms of the LEO." This unambiguous declaration removes the immediate threat of an import ban on Apple Watch models with the redesigned blood oxygen sensor. For Apple, this represents a crucial victory, allowing it to continue selling its flagship wearable devices without the cloud of legal uncertainty and potential sales disruptions that have plagued the product line for months. The decision validates Apple’s extensive engineering and legal efforts to navigate the patent landscape while preserving a key health feature for its users.

Reactions from the Parties Involved

Following the ITC’s announcement, Apple issued a statement to 9to5Mac, expressing its satisfaction with the outcome. "We thank the ITC for its decision, which ensures we can continue to offer this important health feature to our users," an Apple spokesperson stated. The company further highlighted its perspective on the broader legal battle: "For more than six years, Masimo has waged a relentless legal campaign against Apple, and nearly all of its claims have been rejected. We will always defend our innovations, and remain focused on what we do best: delivering the best products and services in the world for our users."

Apple also emphasized its commitment to health innovation, stating its pleasure in continuing to offer the redesigned Blood Oxygen feature, alongside other critical health tools like the ECG app and irregular rhythm notifications, to its U.S. users. The company underscored the significant research and development efforts dedicated to integrating health, wellness, and safety features across its product ecosystem, always with a strong focus on user privacy. This statement reflects Apple’s consistent narrative of prioritizing user health and innovation while defending against what it perceives as aggressive legal tactics.

While Masimo has not yet released an official statement specifically on today’s ITC decision, it is highly probable that the company will express disappointment and reiterate its commitment to protecting its intellectual property. Based on their historical actions, Masimo is expected to review all available legal avenues, which include appealing the ITC’s decision to the U.S. Court of Appeals for the Federal Circuit. This federal appellate court specializes in patent law and would be the next logical step for Masimo to pursue its claims. In previous instances, Masimo CEO Joe Kiani has been vocal about the importance of patent protection for smaller innovators against larger tech companies, and it is likely he will continue to advocate for Masimo’s position, emphasizing the foundational nature of their patented technologies. Industry analysts suggest Masimo’s legal strategy has always been multi-pronged, and this setback, while significant, may not signal the end of their challenges against Apple.

Broader Implications for Apple and the Wearable Health Industry

This ITC ruling carries substantial implications for Apple, Masimo, and the broader wearable health technology industry. For Apple, the immediate benefit is the complete removal of the threat of an import ban on its Apple Watch models in the crucial U.S. market. This ensures uninterrupted sales and the ability to market the full suite of health features, including blood oxygen monitoring, which is a significant differentiator for the Apple Watch Ultra and Series 9. The decision validates Apple’s ability to innovate not just in product design but also in legal strategy, demonstrating its capacity to adapt and redesign features under intense regulatory scrutiny. This win reinforces Apple’s position as a leader in health tech and mitigates potential financial losses from restricted sales. It also sends a message that Apple is prepared to vigorously defend its products and designs against patent infringement claims.

For Masimo, the decision is a notable setback. While they still have the option to appeal to the Federal Circuit, the ITC’s unanimous decision not to review the ALJ’s finding suggests a strong legal basis for Apple’s redesign. This outcome could impact Masimo’s stock performance and investor confidence, as a primary objective of their legal campaign was to gain leverage or secure licensing agreements from Apple. The cost of protracted litigation against a tech giant like Apple is immense, and without a favorable ruling, Masimo may need to reassess its strategy. However, their continued pursuit of the case underscores the deep conviction they hold regarding their intellectual property.

More broadly, this case sets an important precedent for the wearable technology and digital health sectors. It highlights the complex interplay between innovation, intellectual property, and competition. Companies developing advanced health features must navigate a dense landscape of existing patents, leading either to licensing agreements or meticulous "design-arounds." The Apple-Masimo saga illustrates the high stakes involved when established medical device companies confront consumer tech giants entering their traditional domains. It also emphasizes the critical role of regulatory bodies like the ITC in shaping market dynamics and enforcing patent law. This case may encourage other tech companies to invest more heavily in patent analysis and defensive patent strategies, potentially leading to more innovation-by-design-around, or conversely, fostering more cross-licensing discussions to avoid costly legal battles. Consumers, meanwhile, benefit from continued access to advanced health monitoring features, albeit sometimes after lengthy legal skirmishes determine their availability.

The Road Ahead for Masimo

While today’s ITC decision is a significant blow to Masimo’s efforts to halt Apple Watch sales, the legal battle is not necessarily over. As noted, Masimo retains the right to appeal the ITC’s ruling to the U.S. Court of Appeals for the Federal Circuit. This court has exclusive jurisdiction over appeals in patent cases from U.S. district courts and appeals from decisions of the U.S. International Trade Commission concerning unfair practices in import trade. An appeal to the Federal Circuit would involve a review of the ITC’s legal interpretation and factual findings, and it could potentially prolong the dispute for many more months, if not years.

However, the bar for overturning an ITC decision at the Federal Circuit is high, especially when the Commission has declined to review an Administrative Law Judge’s finding of non-infringement, implying strong confidence in the initial determination. Masimo would need to demonstrate that the ITC made a legal error or that its factual findings were unsupported by substantial evidence. Regardless of the outcome of any potential appeal, this legal saga has underscored the intense competition and intellectual property challenges inherent in the rapidly evolving digital health and wearable technology markets. The industry will continue to watch closely how such disputes shape future innovation and market access for these increasingly vital devices.