Masimo Announces Reinstatement of Import Ban on Infringing Apple Watches

Rhea-AI Summary

Masimo (NASDAQ: MASI) celebrates the Federal Circuit's decision to lift the temporary stay on the import ban of certain Apple Watch models, reinstating the U.S. International Trade Commission's import ban and cease and desist order on Apple watches infringing Masimo's patented pulse oximetry technology. The CEO, Joe Kiani, emphasizes the importance of upholding American inventors' rights and highlights the superiority of Masimo's pulse oximetry technology over Apple Watch's. Masimo's FDA-cleared W1® health watch is positioned as a more reliable alternative, with proven benefits in medical settings.

Positive

• The Federal Circuit's decision reinforces Masimo's position in protecting its patented pulse oximetry technology.
• Masimo's FDA-cleared W1® health watch has been proven to be more reliable than Apple Watch's pulse oximeter in medical use cases.

Negative

• The press release does not provide specific financial data or figures to demonstrate the impact of the Federal Circuit's decision on Masimo's business or stock performance.

Legal Expert

The lifting of the temporary stay on the import ban of certain Apple Watch models by the Federal Circuit has significant legal implications. This action underscores the strength and enforceability of patents within the United States and serves as a reminder that intellectual property laws are designed to protect the rights of inventors against infringement by others, regardless of the infringing party's size or influence. The reinstatement of the import ban serves as a deterrent to patent infringement and reinforces the notion that legal recourse is available to patent holders. It also highlights the critical role of the U.S. International Trade Commission in regulating international trade matters related to intellectual property.

Medical Research Analyst

From a medical technology perspective, the dispute emphasizes the importance of clinically validated and FDA-approved devices for medical use. Masimo's pulse oximetry technology, which is widely used in clinical settings, has been shown to be reliable in various studies. The fact that the Apple Watch's pulse oximeter was not cleared by the FDA for medical use raises concerns about the accuracy and reliability of consumer-grade devices for health monitoring. Masimo's study suggesting that the Apple Watch missed over 90% of potentially life-threatening events is alarming and could have significant implications for consumer safety and the perception of wearable technology in healthcare.

Market Research Analyst

This development may have a considerable impact on the market dynamics within the wearable technology sector. Apple, as a major player in the industry, could experience disruptions in its supply chain and sales figures for the impacted Apple Watch models. This could also influence consumer confidence and potentially benefit competitors who offer similar technologies without patent infringement issues. Furthermore, the news could impact investor sentiment towards both Masimo and Apple, as the market often reacts to legal developments that affect a company's product offerings and competitive positioning. It will be important to monitor the market's response to this ruling and the subsequent strategies of both companies.

IRVINE, Calif.--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI), a global leader in innovative noninvasive monitoring technologies, welcomes the Federal Circuit’s ruling to lift the temporary stay on the import ban of certain Apple Watch models. This decision reinstates the U.S. International Trade Commission’s import ban and cease and desist order on Apple watches that were found to infringe Masimo’s patented pulse oximetry technology.

Masimo W1® (Photo: Business Wire)

“The Federal Circuit's decision to lift the temporary stay is a victory for the integrity of the American patent system and the safety of people relying on pulse oximetry,” said Joe Kiani, Founder and CEO of Masimo. “It affirms that even the largest and most powerful companies must respect the intellectual rights of American inventors and must deal with the consequences when they are caught infringing others’ patents.”

Masimo has previously made available a study showing that Apple Watch’s pulse oximetry missed over 90% of potentially life-threatening events. The Apple Watch pulse oximeter was not cleared by the United Stated Food and Drug Administration for medical use. On the other hand, the Masimo W1^® health watch was recently cleared by the FDA for its indicated medical uses, including continuous pulse oximetry. Masimo’s pulse oximetry technology is used on over 200 million patients in hospitals a year¹ and has been proven to help save babies’ eyesight in the neonatal ICU,² detect critical congenital heart defects in newborns,³ and save the lives of patients in post-surgical wards who are taking opioids.^4-7

@Masimo | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁸ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^® and the Masimo W1® medical watch. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius Tº^®, Masimo W1 Sport, and Masimo Stork™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

RPVi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Estimate: Masimo data on file.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696
8. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo W1^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo W1, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks that MightySat may not soon be available for purchase at retail and drug stores across the country and online; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240117431473/en/

Masimo

Evan Lamb

949-396-3376

elamb@masimo.com

Source: Masimo

What is the ticker symbol for Masimo?

The ticker symbol for Masimo is MASI.

What was the Federal Circuit's ruling regarding Apple Watch models?

The Federal Circuit's ruling lifted the temporary stay on the import ban of certain Apple Watch models, reinstating the U.S. International Trade Commission's import ban and cease and desist order on Apple watches infringing Masimo's patented pulse oximetry technology.

What is the significance of Masimo's FDA-cleared W1® health watch?

Masimo's FDA-cleared W1® health watch is positioned as a more reliable alternative to Apple Watch's pulse oximeter, with proven benefits in medical settings.

What are the medical uses of Masimo's pulse oximetry technology?

Masimo's pulse oximetry technology has been proven to help save babies' eyesight in the neonatal ICU, detect critical congenital heart defects in newborns, and save the lives of patients in post-surgical wards who are taking opioids.