Zynex Announces Completion of Its Laser Pulse Oximetry Trial
Zynex (NASDAQ: ZYXI) has completed its clinical verification trial for the NiCO™ pulse oximeter at Duke University, marking a important milestone before FDA 510(k) submission. The device uses innovative laser technology to directly measure blood oxygenation levels, unlike traditional LED pulse oximeters that only provide estimates.
The NiCO technology aims to address accuracy issues present in current LED pulse oximeters, particularly for individuals with darker skin pigmentation. This development represents Zynex's strategic entry into the multi-billion dollar pulse oximetry market. The company will now proceed with final safety testing before submitting for FDA clearance.
Zynex (NASDAQ: ZYXI) ha completato il suo trial di verifica clinica per il pulsossimetro NiCO™ presso la Duke University, segnando un importante traguardo prima della presentazione della domanda FDA 510(k). Il dispositivo utilizza una tecnologia laser innovativa per misurare direttamente i livelli di ossigenazione del sangue, a differenza dei tradizionali pulsossimetri a LED che forniscono solo stime.
La tecnologia NiCO mira a affrontare i problemi di accuratezza presenti nei pulsossimetri a LED attuali, in particolare per le persone con pigmentazione della pelle più scura. Questo sviluppo rappresenta l'ingresso strategico di Zynex nel mercato dei pulsossimetri, che vale diversi miliardi di dollari. L'azienda procederà ora con i test di sicurezza finali prima di presentare la richiesta di approvazione alla FDA.
Zynex (NASDAQ: ZYXI) ha completado su ensayo de verificación clínica para el pulsioxímetro NiCO™ en la Universidad de Duke, marcando un hito importante antes de la presentación de la solicitud FDA 510(k). El dispositivo utiliza una tecnología láser innovadora para medir directamente los niveles de oxigenación de la sangre, a diferencia de los pulsioxímetros tradicionales de LED que solo proporcionan estimaciones.
La tecnología NiCO tiene como objetivo abordar los problemas de precisión presentes en los pulsioxímetros de LED actuales, particularmente para las personas con pigmentación más oscura de la piel. Este desarrollo representa la entrada estratégica de Zynex en el mercado de pulsioxímetros, valorado en miles de millones de dólares. La empresa ahora procederá con las pruebas finales de seguridad antes de presentar la solicitud de aprobación de la FDA.
Zynex (NASDAQ: ZYXI)는 듀크 대학교에서 NiCO™ 맥박 산소 측정기의 임상 검증 시험을 완료하였으며, 이는 FDA 510(k) 제출 전에 중요한 이정표가 됩니다. 이 장치는 전통적인 LED 맥박 산소 측정기가 단지 추정치만 제공하는 것과 달리 혈중 산소 포화도를 직접 측정하기 위해 혁신적인 레이저 기술을 사용합니다.
NiCO 기술은 특히 피부 색소가 더 어두운 개인들에게서 보이는 현재 LED 맥박 산소 측정기에서의 정확도 문제를 해결하는 것을 목표로 하고 있습니다. 이 개발은 Zynex의 수십억 달러 규모의 맥박 산소 측정기 시장으로 전략적으로 진입하는 것을 의미합니다. 회사는 이제 FDA 승인 신청 전에 최종 안전 테스트를 진행할 것입니다.
Zynex (NASDAQ: ZYXI) a achevé son essai de vérification clinique pour le pouls oxymètre NiCO™ à l'Université de Duke, marquant une étape importante avant la soumission de l'approbation FDA 510(k). L'appareil utilise une technologie laser innovante pour mesurer directement les niveaux d'oxygénation du sang, contrairement aux pouls oxymètres traditionnels à LED qui ne fournissent que des estimations.
La technologie NiCO vise à résoudre les problèmes de précision présents dans les pouls oxymètres à LED actuels, en particulier pour les individus ayant une pigmentation de peau plus foncée. Ce développement représente l'entrée stratégique de Zynex sur le marché des pouls oxymètres, qui pèse des milliards de dollars. L'entreprise procédera maintenant à des tests de sécurité finaux avant de soumettre une demande d'approbation à la FDA.
Zynex (NASDAQ: ZYXI) hat seine klinische Verifizierung des NiCO™ Puls-Oximeters an der Duke University abgeschlossen, was einen wichtigen Meilenstein vor der FDA 510(k) Einreichung darstellt. Das Gerät verwendet innovative Lasertechnologie, um die Sauerstoffsättigungswerte im Blut direkt zu messen, im Gegensatz zu herkömmlichen LED-Puls-Oximetern, die nur Schätzungen liefern.
Die NiCO-Technologie zielt darauf ab, die Genauigkeitsprobleme der aktuellen LED-Puls-Oximeter zu lösen, insbesondere bei Personen mit dunklerer Hautfarbe. Diese Entwicklung stellt den strategischen Eintritt von Zynex in den milliardenschweren Markt für Puls-Oximeter dar. Das Unternehmen wird nun mit den abschließenden Sicherheitstests fortfahren, bevor es einen Antrag auf FDA-Zulassung einreicht.
- Completion of clinical verification trial, a key milestone for FDA 510(k) submission
- Technology addresses accuracy limitations of current LED pulse oximeters
- Strategic entry into multi-billion dollar pulse oximetry market
- Advanced laser technology offering direct measurement versus estimates
- Product still requires FDA clearance before commercialization
- Additional safety testing needed before 510(k) submission
Insights
Trial completion is a key milestone required by the FDA prior to submission of a 510(k) for clearance to market and sell the NiCO device for clinical use. With the completion of this study, Zynex now turns to final testing to ensure the operational safety of the device prior to 510(k) submission.
Zynex's NiCO pulse oximeter utilizes highly precise laser technology to measure blood oxygenation levels directly, as opposed to current pulse oximeter products, which only estimate oxygenation levels using LEDs. LED pulse oximeters have been shown to mismeasure oxygen levels in several populations, most prominently in individuals with darker skin pigmentation.
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.
"The completion of our verification study is a pivotal event for Zynex Monitoring and the result of an enormous team effort. The bulk of the hard work is behind us at this point as we turn to submit NiCO for FDA clearance officially," said Donald Gregg, President of Zynex Monitoring Solutions.
"NiCO will be the first Zynex monitoring product to enter a mature and growing market whose entry will be enabled by its game-changing capabilities. We are excited to finally have all the required clinical studies behind us as we prepare our application for FDA clearance," added Thomas Sandgaard, Founder and CEO of Zynex.
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.zynex.com.
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SOURCE Zynex, Inc.
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