Masimo W1® Medical Watch Receives FDA 510(k) Clearance for Connectivity to the Masimo SafetyNet® Telemonitoring System
Masimo (NASDAQ: MASI) announced FDA 510(k) clearance for the Masimo W1® medical watch's connectivity to the Masimo SafetyNet® telemonitoring system. This integration allows continuous, accurate wrist-based measurements to be relayed to caregivers via the Masimo Secure Health Data Cloud. The Masimo W1 Medical, which received FDA clearance last year for continuous SpO2 and pulse rate monitoring, can now transmit data to the SafetyNet smartphone app and web-based clinician portal.
The Masimo W1 features the MW-1 sensor module, incorporating Signal Extraction Technology® pulse oximetry and rainbow® Pulse CO-Oximetry. It offers real-time display of SpO2, pulse rate, perfusion index, and ECG-derived heart rate. With Bluetooth connectivity, patients can input symptoms, view data trends, and conduct virtual visits through the SafetyNet app. Clinicians can access patient data, receive customized notifications, and integrate information into EMRs.
Masimo (NASDAQ: MASI) ha annunciato l'approvazione 510(k) dalla FDA per la connettività del orologio medico Masimo W1® al sistema di telemonitoraggio Masimo SafetyNet®. Questa integrazione consente che le misurazioni continue e precise basate su polso vengano trasmesse ai caregiver tramite il Masimo Secure Health Data Cloud. Il Masimo W1 Medical, che ha ricevuto l'approvazione della FDA lo scorso anno per il monitoraggio continuo di SpO2 e della frequenza cardiaca, può ora trasmettere dati all'app per smartphone SafetyNet e al portale web per i clinici.
Il Masimo W1 è dotato del modulo sensore MW-1, che incorpora la tecnologia di estrazione del segnale® per la pulse oximetry e la pulse CO-oximetry rainbow®. Offre una visualizzazione in tempo reale di SpO2, frequenza cardiaca, indice di perfusione e frequenza cardiaca derivata da ECG. Con la connettività Bluetooth, i pazienti possono inserire sintomi, visualizzare le tendenze dei dati e condurre visite virtuali tramite l'app SafetyNet. I clinici possono accedere ai dati dei pazienti, ricevere notifiche personalizzate e integrare le informazioni nei registri elettronici dei pazienti.
Masimo (NASDAQ: MASI) anunció la aprobación 510(k) de la FDA para la conectividad del reloj médico Masimo W1® al sistema de telemonitoreo Masimo SafetyNet®. Esta integración permite que las mediciones continuas y precisas basadas en la muñeca sean transmitidas a los cuidadores a través del Masimo Secure Health Data Cloud. El Masimo W1 Medical, que recibió la aprobación de la FDA el año pasado para el monitoreo continuo de SpO2 y la frecuencia cardíaca, ahora puede transmitir datos a la aplicación para teléfonos inteligentes de SafetyNet y al portal web para clínicos.
El Masimo W1 cuenta con el módulo de sensor MW-1, que incorpora la tecnología de extracción de señal® para la pulsioximetría y la pulsioximetría rainbow®. Ofrece una visualización en tiempo real de SpO2, frecuencia cardíaca, índice de perfusión y frecuencia cardíaca derivada de ECG. Con conectividad Bluetooth, los pacientes pueden ingresar síntomas, ver tendencias de datos y realizar visitas virtuales a través de la aplicación SafetyNet. Los clínicos pueden acceder a los datos de los pacientes, recibir notificaciones personalizadas e integrar información en los registros electrónicos de salud.
Masimo (NASDAQ: MASI)는 Masimo W1® 의료 시계의 Masimo SafetyNet® 원격 모니터링 시스템 연결에 대한 FDA 510(k) 승인을 발표했습니다. 이 통합은 지속적이고 정확한 손목 기반 측정값이 Masimo Secure Health Data Cloud를 통해 돌보는 이들에게 전달될 수 있도록 합니다. Masimo W1 Medical은 지난 해 FDA의 지속적 SpO2 및 맥박 속도 모니터링 승인을 받았으며, 이제 SafetyNet 스마트폰 앱과 웹 기반 임상의 포털로 데이터를 전송할 수 있습니다.
Masimo W1은 MW-1 센서 모듈을 갖추고 있으며, 여기에는 신호 추출 기술® 맥박 산소측정법과 rainbow® 펄스 CO-산소측정법이 포함됩니다. 실시간으로 SpO2, 맥박 속도, 관류 지수 및 ECG 유래 심박수를 표시합니다. 블루투스 연결을 통해 환자는 증상을 입력하고, 데이터 추세를 보고, SafetyNet 앱을 통해 가상 방문을 진행할 수 있습니다. 임상의들은 환자 데이터를 접근하고 맞춤 알림을 받을 수 있으며 EMR에 정보를 통합할 수 있습니다.
Masimo (NASDAQ: MASI) a annoncé l'approbation 510(k) de la FDA pour la connectivité de la montre médicale Masimo W1® au système de télémonitoring Masimo SafetyNet®. Cette intégration permet de transmettre des mesures continue et précises basées sur le poignet aux soignants via le Masimo Secure Health Data Cloud. Le Masimo W1 Medical, qui a reçu l'approbation de la FDA l'année dernière pour une surveillance continue de SpO2 et de la fréquence cardiaque, peut désormais transmettre des données à l'application pour smartphone SafetyNet et au portail web pour les cliniciens.
Le Masimo W1 dispose du module capteur MW-1, intégrant la technologie d'extraction de signal® pour la pulsoxymétrie et la pulsoxymétrie rainbow®. Il offre un affichage en temps réel de SpO2, de la fréquence cardiaque, de l'indice de perfusion et de la fréquence cardiaque dérivée de l'ECG. Grâce à la connectivité Bluetooth, les patients peuvent saisir des symptômes, visualiser les tendances des données et effectuer des visites virtuelles via l'application SafetyNet. Les cliniciens peuvent accéder aux données des patients, recevoir des notifications personnalisées et intégrer des informations dans les dossiers médicaux électroniques.
Masimo (NASDAQ: MASI) gab die FDA 510(k)-Genehmigung für die Konnektivität der Masimo W1®-medizinischen Uhr mit dem Masimo SafetyNet®-Telemonitoringsystem bekannt. Diese Integration ermöglicht es, kontinuierliche, präzise, am Handgelenk basierende Messungen über die Masimo Secure Health Data Cloud an Pflegekräfte zu übermitteln. Die Masimo W1 Medical, die im letzten Jahr von der FDA die Genehmigung für die kontinuierliche Überwachung von SpO2 und Pulsfrequenz erhielt, kann nun Daten an die SafetyNet-Smartphone-App und das webbasierte Klinikerportal übertragen.
Die Masimo W1 verfügt über das MW-1-Sensormodul, das Signal Extraction Technology® Puls-Oximetrie und rainbow® Puls-CO-Oximetrie integriert. Sie bietet eine Echtzeit-Anzeige von SpO2, Pulsfrequenz, Perfusionsindex und aus dem EKG abgeleitete Herzfrequenz. Mit Bluetooth-Konnektivität können Patienten Symptome eingeben, Datentrends anzeigen und virtuelle Besuche über die SafetyNet-App durchführen. Kliniker können auf Patientendaten zugreifen, maßgeschneiderte Benachrichtigungen erhalten und Informationen in die EMRs integrieren.
- FDA 510(k) clearance for Masimo W1® medical watch's connectivity to SafetyNet® telemonitoring system
- Integration allows continuous, accurate wrist-based measurements to be relayed to caregivers
- Expansion of Masimo SafetyNet capabilities, enhancing remote patient monitoring
- Potential for improved health outcomes through continuous monitoring and data sharing
- None.
Insights
The FDA 510(k) clearance for Masimo W1® Medical Watch's connectivity to the SafetyNet® system is a significant advancement in remote patient monitoring. This integration allows continuous, wrist-based SpO2 and pulse rate measurements to be seamlessly transmitted to caregivers via the Masimo Secure Health Data Cloud. The system's ability to provide real-time data and customized notifications to caregivers enhances patient care beyond traditional hospital settings.
The Masimo MW-1 module, incorporating 30 years of pulse oximetry technology, offers high-resolution SpO2, PR, perfusion index and ECG-derived heart rate. This level of comprehensive monitoring in a wearable device is unprecedented in the consumer medical device market. The integration with the SafetyNet app and clinician portal creates a powerful ecosystem for remote patient management, potentially reducing hospital readmissions and improving overall patient outcomes.
The Masimo W1® and SafetyNet® integration represents a significant leap in telehealth capabilities. By enabling secure Bluetooth connectivity and cloud-based data storage, this system addresses key challenges in remote patient monitoring: data accuracy, real-time transmission and seamless integration with existing healthcare IT infrastructure.
The ability to integrate with electronic medical records (EMRs) is particularly noteworthy, as it streamlines clinical workflows and enhances data continuity. The system's end-to-end encryption and compliance with hospital data security standards are important for widespread adoption. This technology has the potential to transform population health management by providing clinicians with comprehensive, real-time patient data, enabling more proactive and personalized care strategies.
Masimo's FDA clearance for the W1® Medical Watch's connectivity opens up significant market opportunities in the rapidly growing telehealth sector. With the global remote patient monitoring market projected to reach
The integration of advanced monitoring capabilities in a user-friendly wearable format addresses a key consumer demand for non-intrusive health tracking. This could lead to increased adoption rates among both healthcare providers and patients. Additionally, the potential for data-driven insights and predictive care models could create new revenue streams through value-based care partnerships with healthcare providers and insurers.
Secure Bluetooth® Connectivity Allows Continuous, Accurate Wrist-based Measurements to be Seamlessly Relayed to Caregivers via the Masimo Secure Health Data Cloud
Masimo W1® with Masimo SafetyNet® (Photo: Business Wire)
Joe Kiani, Founder and CEO of Masimo, said, “This is an important milestone for better health outcomes. For the first time caregivers can get customized notifications, based on data from an unobtrusive pulse oximeter worn on the wrist of a patient or loved one, in situations where it’s logistically difficult to provide care in person. Masimo W1 Medical with Masimo SafetyNet opens up a world of possibilities for caregivers looking to improve quality of care and ultimately improve outcomes for those they care for.”
Mr. Kiani continued, “We’ve been excited to see how institutions in
The clinical power of Masimo W1 Medical comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates over 30 years of Signal Extraction Technology® pulse oximetry and rainbow® Pulse CO-Oximetry knowledge into a single wearable module. It has an integrated optical sensor and electrocardiogram (ECG) electrode pads that can be used to detect physiological signals. The Masimo MW-1 module also processes these signals using Masimo’s proprietary signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and HR from an ECG.
The continuous data from the Masimo MW-1 module is displayed in real time on the Masimo W1 watch touchscreen in an easy-to-interpret format. With the addition of Bluetooth connectivity, patients can now also take full advantage of the powerful Masimo SafetyNet app, using their phone to input additional symptoms into CarePrograms designed by their clinicians, view their live data and trends, conduct virtual visits with clinicians, and view educational resources.
In turn, clinicians back at the hospital or doctor’s office can examine data and trends and receive customized notifications within the Masimo SafetyNet clinician portal – enabling care providers to manage their patients beyond the boundaries of the hospital. With Masimo SafetyNet, clinicians gain valuable insight into how their patients’ physiological data changes as they go about their day, helping them better understand their patients so that they can identify and prioritize patients who need follow up. They can more easily track patient progress, tailor remote care programs to match each patient’s needs, and streamline their workflows with high-fidelity reports, rich analytics, and the integration of reliable medical data into electronic medical records (EMRs).
In addition to making patient data available to hospital clinicians via the clinician portal, patients can configure Masimo SafetyNet so that their data can be shared with other types of caregivers, such as a family member taking care of their elderly parents or a loved one. Remote caregivers can also receive customized updates – helping better assess when to check in with their loved one.
Making the secure transmission and storage of patient medical data possible for Masimo SafetyNet is the Masimo SafetyNet cloud: fast, scalable, and reliably available health cloud storage tailored to meet hospitals’ strict standards. The Masimo SafetyNet cloud not only provides the highest level of end-to-end encryption to ensure that data privacy and security are maintained, but gives clinicians access to trended patient data and waveforms wherever they are – supporting more informed clinical insight and analysis. In addition, the comprehensive data set stored in the cloud can be used to generate robust, highly detailed reports, making Masimo SafetyNet a true population health management platform.
Masimo SafetyNet – which also connects to other wearables, like Masimo Radius PPG® for tetherless fingertip pulse oximetry and Radius Tº® for continuous wireless thermometry, as well as a variety of spot-check devices – is now an even more robust, powerful, and comprehensive telemonitoring solution.
The Masimo W1 medical watch and the integrated Masimo MW-1 module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.
@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.1 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,2 improve CCHD screening in newborns,3 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,8 and is the primary pulse oximetry at all 10 top
RPVi has not received FDA 510(k) clearance and is not available for sale in
References
- 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.
- 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.
- 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.
- 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.
- Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
- 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.
- 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.
- Estimate: Masimo data on file.
- https://www.newsweek.com/rankings/worlds-best-hospitals-2024/united-states
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® and Masimo SafetyNet®. 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 and Masimo, 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 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/20240812430878/en/
Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
Source: Masimo
FAQ
What new FDA clearance did Masimo (MASI) receive for its W1® medical watch?
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