Zynex Announces Open Oximetry Project Membership
Zynex (NASDAQ: ZYXI) has joined the Open Oximetry Project's Collaborative Community as an industry member. The project, led by UC San Francisco's Center for Health Equity in Surgery and Anesthesia, aims to improve pulse oximeter safety and accuracy across all populations. Zynex Monitoring Solutions is developing the NiCO™ pulse oximeter, which uses laser technology instead of traditional LED technology for more accurate blood oxygenation measurement, particularly addressing known inaccuracies in measuring oxygen levels in individuals with darker skin pigmentation. The company is in final verification studies before FDA 510(k) submission, targeting entry into the multi-billion dollar pulse oximetry market.
Zynex (NASDAQ: ZYXI) ha aderito alla Comunità Collaborativa del Progetto Open Oximetry come membro dell'industria. Il progetto, guidato dal Centro per l'Equità nella Salute in Chirurgia e Anestesia dell'UC San Francisco, mira a migliorare la sicurezza e l'accuratezza dei pulsossimetri in tutte le popolazioni. Zynex Monitoring Solutions sta sviluppando il pulsossimetro NiCO™, che utilizza la tecnologia laser invece della tradizionale tecnologia LED per una misurazione più accurata dell'ossigenazione del sangue, affrontando in particolare le imprecisioni note nella misurazione dei livelli di ossigeno in individui con pigmentazione della pelle più scura. L'azienda è nelle fasi finali degli studi di verifica prima della sottomissione al FDA 510(k), puntando a entrare nel mercato dei pulsossimetri da miliardi di dollari.
Zynex (NASDAQ: ZYXI) se ha unido a la Comunidad Colaborativa del Proyecto Open Oximetry como miembro de la industria. El proyecto, liderado por el Centro de Equidad en Salud en Cirugía y Anestesia de la UC San Francisco, tiene como objetivo mejorar la seguridad y precisión de los oxímetros de pulso en todas las poblaciones. Zynex Monitoring Solutions está desarrollando el oxímetro de pulso NiCO™, que utiliza tecnología láser en lugar de la tecnología LED tradicional para medir de manera más precisa la oxigenación de la sangre, abordando especialmente las inexactitudes conocidas en la medición de los niveles de oxígeno en individuos con pigmentación de piel más oscura. La empresa se encuentra en los estudios finales de verificación antes de la presentación del FDA 510(k), con el objetivo de ingresar al mercado de los oxímetros de pulso de miles de millones de dólares.
Zynex (NASDAQ: ZYXI)는 업계 회원으로 Open Oximetry Project의 Collaborative Community에 합류했습니다. 이 프로젝트는 UC 샌프란시스코의 수술 및 마취 건강 공평 센터가 주도하며 모든 인구에서 맥박 산소측정기의 안전성과 정확성을 개선하는 것을 목표로 합니다. Zynex Monitoring Solutions는 전통적인 LED 기술 대신 레이저 기술을 사용하는 NiCO™ 맥박 산소측정기를 개발 중입니다. 이 기술은 피부 색소가 더 짙은 개인에서 산소 수준 측정의 알려진 부정확성을 해결하기 위해 특히 더 정확한 혈액 산소 측정을 제공합니다. 이 회사는 FDA 510(k) 제출을 위한 최종 검증 연구 단계에 있으며, 수십억 달러 규모의 맥박 산소측정기 시장 진입을 목표로 하고 있습니다.
Zynex (NASDAQ: ZYXI) a rejoint la Communauté Collaborative du Projet Open Oximetry en tant que membre industriel. Le projet, dirigé par le Centre pour l'Équité en Santé en Chirurgie et Anesthésie de l'UC San Francisco, vise à améliorer la sécurité et la précision des oxymètres de pouls pour toutes les populations. Zynex Monitoring Solutions est en train de développer l'oxymètre de pouls NiCO™, qui utilise la technologie laser au lieu de la technologie LED traditionnelle pour mesurer plus précisément l'oxygénation du sang, en s'attaquant notamment aux inexactitudes connues dans la mesure des niveaux d'oxygène chez les individus avec une pigmentation de peau plus foncée. L'entreprise est actuellement dans les études de vérification finales avant la soumission au FDA 510(k), visant à entrer sur le marché des oxymètres de pouls de plusieurs milliards de dollars.
Zynex (NASDAQ: ZYXI) ist als Industriebeteiligter der Collaborative Community des Open Oximetry Projekts beigetreten. Das Projekt, das vom Center for Health Equity in Surgery and Anesthesia der UC San Francisco geleitet wird, zielt darauf ab, die Sicherheit und Genauigkeit von Pulsoximetern in allen Bevölkerungsgruppen zu verbessern. Zynex Monitoring Solutions entwickelt das NiCO™ Pulsoximeter, das Laser-Technologie anstelle der traditionellen LED-Technologie verwendet, um die Messung der Blutoxygenierung genauer zu gestalten, insbesondere um bekannte Ungenauigkeiten bei der Messung der Sauerstoffwerte bei Personen mit dunklerer Hautpigmentierung anzugehen. Das Unternehmen befindet sich in den letzten Verifizierungsstudien vor der FDA 510(k) Einreichung und strebt den Eintritt in den mehr Milliarden US-Dollar schweren Markt für Pulsoximetrie an.
- Company is in final stages of verification studies for NiCO™ pulse oximeter before FDA 510(k) submission
- Strategic expansion into the multi-billion dollar pulse oximetry market
- Development of innovative laser-based technology addressing accuracy issues in current LED pulse oximeters
- None.
Insights
The development of NiCO pulse oximeter using laser technology represents a significant potential breakthrough in medical monitoring. Current LED-based pulse oximeters have documented accuracy issues, particularly in patients with darker skin tones, which has become a major healthcare equity concern. The multi-billion dollar pulse oximetry market presents a substantial opportunity for Zynex if they can successfully demonstrate superior accuracy with their laser-based technology.
The timing is strategic, with Zynex in final verification studies before FDA 510(k) submission. Joining the Open Oximetry Project adds credibility and provides access to valuable collaboration opportunities with key stakeholders. However, success will ultimately depend on clinical validation, regulatory approval and market adoption. The technology's potential to address known accuracy issues could drive significant market share gains if proven effective.
This strategic move positions Zynex to disrupt the established pulse oximetry market dominated by major medical device companies. The company's membership in the Open Oximetry Project provides valuable networking opportunities and early access to industry developments. With healthcare equity becoming increasingly important, hospitals and healthcare systems are likely to prioritize more accurate monitoring solutions, especially those addressing documented racial disparities in medical care.
While the news signals progress, investors should note that market penetration will require extensive clinical validation and marketing efforts to convince healthcare providers to switch from established vendors. The verification studies completion and subsequent FDA submission will be important near-term catalysts to watch.
The Open Oximetry Project, an initiative led by the University of
In alignment with these objectives, Zynex Monitoring Solutions (ZMS) is developing the NiCO™ pulse oximeter which utilizes laser technology to accurately measure blood oxygenation levels, as opposed to current LED technology, which only estimates oxygenation levels. LED pulse oximeters have been shown to inaccurately measure oxygen levels in several populations, most predominantly on individuals with darker skin pigmentation.
ZMS is currently in the final stages of its verification studies for NiCO, which are required before submitting for full 510(k) clearance by the FDA. Zynex Monitoring Solutions' NiCO product line is a strategic investment for Zynex to enter the multi-billion dollar pulse oximetry market with entirely new pulse oximetry technology. The Company is confident that the clinical value of NiCO's unparalleled precision, accuracy, and safety will provide the right entry into this market space.
"Open Oximetry provides a vital independent service to the public, raising awareness of the shortfalls and performance levels of current oximetry products. This is an important first step in improving patient care and pushing for technology advancements that resolve these well-published and well-recognized monitoring deficiencies." said Donald Gregg, President of Zynex Monitoring Solutions. "We are pleased to join the Collaborative Community of the Open Oximetry Project to contribute to a better understanding of the clinical performance of current LED pulse oximetry and to work toward better healthcare through safer and more inclusive medical monitoring solutions."
About Open Oximetry
Founded at UCSF's Center for Health Equity in Surgery and Anesthesia (CHESA) and the UCSF Hypoxia Lab, the Open Oximetry project was created to improve the safety and precision of pulse oximeters in all populations as these devices have been found to be less accurate in people with darker skin tone. The Open Oximetry Project has organically grown into a hub for bringing together oximetry experts, engineers, academic researchers, clinicians, community members, manufacturers, and regulatory bodies from all geographies and backgrounds. We hope to continue to invite and hold space for diverse voices to work in partnership to tackle these issues.
About Zynex, Inc.
Zynex, founded in 1996, develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for use in hospitals. For additional information, please visit: www.zynexmonitoring.com.
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FAQ
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