masimo apple watch ban
Policy/Regulatory, Product/Vendor Updates

Masimo Welcomes Reinstated Apple Watch Ban

Masimo 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.

“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 States 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

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.

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