Masimo Receives FDA Clearance for Stork™ Over-the-Counter (OTC) Baby Monitoring System

Rhea-AI Summary

Masimo, a global leader in monitoring technologies, received FDA clearance for Stork™, an over-the-counter baby monitoring system for infants up to 18 months. The system provides continuous monitoring of oxygen saturation, pulse rate, and skin temperature without a prescription. It offers visual and audible alarms if readings fall outside preset ranges, utilizing advanced pulse oximetry technology. Stork is available at major retailers and online, with additional alarm features through a mobile app update. Stork features a sleek design, patented SET® sensor technology, and a camera with future AI-based features. It is FDA-cleared for OTC use, suitable for infants and neonates in home environments.

Positive

• Masimo's FDA clearance for the Stork™ baby monitoring system expands its product portfolio, positioning the company in the consumer market segment.

• The Stork™ system leverages Masimo's advanced pulse oximetry technology used in hospitals, enhancing the potential for improved health outcomes for infants.

• The innovative design and features of Stork™, including the SET® sensor technology, offer caregivers real-time monitoring and alerts for infants' vital signs without a prescription.

Negative

• The Stork™ system may face competition in the consumer baby monitoring market, impacting potential market share and revenue growth.

• Despite the FDA clearance, there may be regulatory challenges or restrictions in the future that could affect the distribution and sales of the Stork™ system.

• While Stork™ offers advanced monitoring capabilities, there could be concerns regarding the accuracy and reliability of the system for continuous home use without medical supervision.

With This Clearance, Stork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Babies up to 18 Months, at Home, Without a Prescription

IRVINE, Calif.--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI), a global leader in innovative monitoring technologies currently celebrating its 35^th anniversary, announced FDA clearance of Stork™, a baby monitoring system that provides alarms to parents or other caregivers, for use with healthy babies 0-18 months of age, without the need for a prescription.

Masimo Stork™ (Photo: Business Wire)

The over-the-counter (OTC) version of Stork utilizes the same Masimo pulse oximetry technology that monitors more than 10 million babies in hospitals every year¹ and is used at 9 of the top 10 U.S. hospitals.² The FDA-cleared OTC version of Masimo Stork monitors a baby’s key vitals data including oxygen saturation level (SpO₂), pulse rate (PR), and skin temperature; crucially, Stork notifies caregivers with visual and audible alarms if a baby’s SpO₂ or PR readings fall outside of preset ranges.

Stork leverages the same pulse oximetry technology that has been used on babies in the neonatal intensive care unit (NICU) for decades, helping to improve health outcomes for the youngest and most vulnerable patients. Known as Signal Extraction Technology^®, or SET^®, this technology has helped clinicians reduce the incidence of neonatal blindness from retinopathy of prematurity³ and has led to significant improvements in screening newborns for critical congenital heart disease.⁴

“Bringing your new baby home from the hospital is exciting, but can be nerve- wracking—and it’s something I remember vividly from when my son was born and required at-home monitoring,” said Joe Kiani, Founder and CEO of Masimo. “I believe that by empowering parents and caregivers with the same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident when caring for their baby. It is particularly fitting that we received this clearance and are making this announcement as we celebrate the 35^th anniversary of the company I founded with a mission to improve lives everywhere, especially those of the youngest and most fragile among us. Thirty-five years ago I envisioned Stork. I am so proud of our team for Stork – it is a culmination of science and design at its best.”

Stork bundles are currently available at major and specialty retailers nationwide and at masimo.com as a non-medical device for general health and wellness purposes. Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork App, in an update scheduled to be released this summer. FDA-cleared OTC Stork bundles will be available for purchase online and at retailers this summer.

Masimo’s patented SET^® sensor technology nests within the Stork boot, which is made from an ultra-soft, medical-grade silicone that conforms gently to the baby’s skin and is available in three sizes to ensure a perfect fit as the child grows. The sensor embedded in the boot is the product of meticulous engineering that harnesses decades of expertise in noninvasive monitoring to detect babies’ SpO₂, PR, and skin temperature continuously, with unprecedented accuracy and dependability.

Masimo Stork has a sleek, minimalist design that fits seamlessly into any nursery and on the baby’s foot. The Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, PR, and SpO₂, and a 2K Quad High-Definition (QHD) capable camera with technology supported by the TODA platform from Like Minded Labs. The camera hardware and software architecture are designed to leverage and be compatible with future edge AI-based features, which are in development. The first application of the edge AI technology will be identifying babies who have turned face down. For those who do not require streaming video, or detection via video of babies being face down, the Stork Vitals bundle replaces the camera with a hub, which connects the Stork vital signs sensor/boot to the Stork app, while still allowing parents to hear their baby. Stork also monitors the baby’s room conditions (ambient temperature and humidity).

Masimo Stork is 510(k) cleared for OTC use as a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is indicated for spot-checking and continuous monitoring of SpO₂ and PR during no motion, motion, and low perfusion conditions in infants and neonates who are 0 to 18 months of age and between 6 and 30 lbs. Masimo Stork OTC is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months of age and between 6 and 30 lbs. Masimo Stork is indicated for use in home environments.

Masimo Stork can be used to supplement a caregiver’s decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or low SpO₂; rather, Masimo Stork is intended to provide a notification only when sufficient data are available for analysis.

Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.

@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.⁵ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ 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.² 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. As ranked in U.S. News and World Report. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
3. 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.
4. 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.
5. 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.
6. 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.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8. 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.
9. 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.
10. Estimate: Masimo data on file.

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 Stork™ and SET^®. 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 Stork and SET^®, 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 related to the assumption that Stork OTC monitoring and alarm features will be available through the Masimo Stork App and Stock OTC bundles will be available online and at retailers this summer; 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/20240506510512/en/

Media Contact:

Masimo

Matt Whewell

720-838-0691

Matt.whewell@masimo.com

Source: Masimo

FAQ

What is the FDA clearance for Masimo?

The FDA clearance is for Stork™, an over-the-counter baby monitoring system for infants up to 18 months, offering continuous monitoring of oxygen saturation, pulse rate, and skin temperature without a prescription.

Where can Stork™ be purchased?

Stork™ bundles are available at major and specialty retailers nationwide and online at masimo.com as a non-medical device.

What technology does Stork™ use?

Stork™ utilizes Masimo's pulse oximetry technology and features the SET® sensor technology for accurate monitoring of vital signs.

What is the indication for using Masimo Stork?

Masimo Stork is indicated for spot-checking and continuous monitoring of SpO2 and PR in infants and neonates up to 18 months of age, along with skin temperature measurements in a home environment.

What additional features does Stork offer?

Stork has a sleek design, a camera with future AI-based features for baby monitoring, and the ability to monitor ambient room conditions like temperature and humidity.

Is Masimo Stork suitable for all infants?

Masimo Stork is not intended for infants previously diagnosed with cardiovascular or respiratory diseases and is meant to supplement caregiver decision-making, not replace medical monitoring or treatment.