ProSomnus, MonitAir Partner to Integrate OSA Remote Monitoring
The collaboration integrates data from the ProSomnus RPMO₂ into MonitAir’s platform to support longitudinal tracking.
Tag: Pulse Oximeter
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Intraoral Oximetry Biosensor Earns Patent
Achaemenid Innovations’ wireless oral cavity sensor detects oxygen saturation, pulse rate, actigraphy, and oral appliance use, aiming to overcome skin-tone and environmental limitations of fingertip oximetry.
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FDA Clears OTC Pulse Oximeter Designed for Accuracy Across Skin Tones
The FDA has granted 510(k) clearance for an over-the-counter fingertip pulse oximeter designed to provide accurate blood oxygen readings across all skin tones.
Few Manufacturers Test Pulse Oximeters for Skin Tone Bias
Analysis of FDA clearance documents for pulse oximeters finds increasing but still low compliance with a 2013 FDA non-mandatory recommendation.
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FDA Proposes New Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
The FDA has issued new draft guidance aimed at improving the accuracy and performance of pulse oximeters across different skin tones.
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Laser Tech Outperforms LED Pulse Oximeters in Addressing Racial Bias
A laser-based pulse oximeter demonstrated superior accuracy over LED models in SpO2 measurements across skin tones in a study by the UCSF Hypoxia Lab.
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Laser-Based Pulse Oximeter Advances Toward FDA Submission
Zynex has completed its clinical verification trial for the NiCO laser-based pulse oximeter, a device designed to measure blood oxygen levels more accurately.
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FDA Clears Pulse Oximeter in EvieMED Ring
Movano Health has secured US Food and Drug Administration clearance for the pulse oximeter in the EvieMED Ring.
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BodiMetrics and EnsoData Partner to Enhance Home Sleep Apnea Testing
BodiMetrics and EnsoData have partnered to enhance home sleep apnea testing and monitoring by integrating the EnsoSleep PPG software with BodiMetrics’ circul pro smart ring.
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Movano Focuses on EvieMED Ring FDA Review and New B2B Partnerships
Movano Health’s Q3 update highlights the relaunch of its Evie Ring, progress on FDA 510(k) clearance for the EvieMED Ring, and new business initiatives focused on expanding healthcare partnerships and clinical wearables.
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Movano Provides Update on EvieMED Ring’s FDA Review Process
Movano Health has submitted a complete response package to the FDA regarding further questions on the EvieMED Ring.
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Movano to Respond to FDA Questions as Part of EvieMED Final Review Phase
After addressing initial FDA questions about the device’s features, the company now plans to submit updated responses to additional clarifying questions from the agency.
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What Exactly Is Software as a Medical Device?
With increasing FDA clearances for standalone software in sleep medicine, “software as a medical device” is becoming a key term. Experts explain what SaMD entails and explore its unique advantages and challenges.
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Researchers Identify Simple Method to Screen for Sleep Apnea in Stroke Patients
Researchers found the method may offer a cost-effective solution to screen for sleep apnea in stroke patients, addressing a gap in early detection and treatment.
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Partnership Aims to Improve Health Equity in Remote Patient Monitoring
The partnership integrates Nonin Medical’s Model 3230 pulse oximeter, designed for accurate readings across skin tones, into Tenovi’s remote patient monitoring system.
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FDA Seeks Additional Information on Movano Health’s EvieMED Ring
Movano Health is pursuing FDA clearance for its smart ring designed to provide medical device functionality and wellness metrics.
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FDA’s Promised Guidance on Pulse Oximeters Unlikely To End Decades of Racial Bias
As the FDA polishes draft guidelines it had hoped to publish by Oct 1, clinicians and scientists are unsure what to expect.
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Garmin’s Latest Smartwatch Provides Sleep Tracking, GPS, and Health Monitoring
Garmin’s newest smartwatch includes built-in GPS, advanced sleep tracking with heart rate variability, and comprehensive health monitoring features aimed at improving wellness.
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