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Tag: Pulse oximeters


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In brief: Cath codes, sleep predictions, wildfire support, pulse ox guidance

January 10, 2025HME News Staff

WASHINGTON – The Pricing, Data Analysis and Coding (PDAC) contractor for CMS seeks primary contact information from manufacturers and distributors as it prepares to roll out new HCPCS codes for hydrophilic intermittent urinary catheters on Jan. 1, 2026, AAHomecare reports.  Manufacturers and distributors can provide their primary contact by completing this form by March 31. Over the course of the year, the PDAC will work with the primary contact to determine if their products qualify...

California wildfires, Henry Schein, Intermittent catheters, McKesson, National Sleep Foundation, PDAC, Pulse oximeters, United Spinal


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FDA issues draft guidance on pulse oximeters 

January 9, 2025HME News Staff

WASHINGTON – The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a range of skin pigmentations. The FDA is requesting comments on “Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations” for 60 days, until March 10. The draft guidance includes information...

draft guidance, Food & Drug Administration (FDA), Oxygen Concentrator, Pulse oximeters


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Nonin gets OK for OTC oximeter 

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Nonin gets OK for OTC oximeter 

December 3, 2024HME News Staff

PLYMOUTH, Minn. – Nonin Medical has secured U.S. Food and Drug Administration clearance for the TruO2 OTC, an over-the-counter fingertip pulse oximeter that’s accurate for patients of all skin colors. It’s the company’s first FDA-cleared, over-the-counter fingertip pulse oximeter. “Over the past several years, the U.S. market has been flooded with poor quality health and wellness-grade pulse oximeters which are not regulated by the FDA,” said John Hastings, CEO...

FDA clearance, Nonin Medical, Pulse oximeters, TruO2 OTC


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Movano secures clearance for pulse ox 

December 2, 2024HME News Staff

PLEASANTON, Calif. – Movano Health has announced U.S. Food and Drug Administration 510(k) clearance for the pulse oximeter in its EvieMED Ring. The company says the clearance enables it to pursue multi-billion-dollar business opportunities for health monitoring solutions needed for applications such as clinical trials, post-clinical trial management and remote patient monitoring for both health care providers and payers. "We launched the Evie Ring in the consumer wearable market, but our...

EvieMED Ring, FDA clearance, Movano Health, Pulse oximeters, Remote Patient Monitoring


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Owlet, Wheel speed up access to monitoring device  

April 29, 2024HME News Staff

LEHI, Utah – Virtual care provider Wheel can now provide caregivers with timely prescriptions for BabySat, Owlet’s infant pulse oximeter, through a new strategic partnership. The new BabySat virtual telehealth services platform, managed and powered by Wheel, also integrates with DME suppliers who accept and can bill for the product through insurance providers, which may offer up to 100% reimbursement. “Home monitoring plays a pivotal role in safeguarding at-risk infants by improving...

Owlet, Pulse oximeters, virtual care, Wheel


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BodiMetrics gets green light for pulse oximeter 

September 19, 2023HME News Staff

LOS ANGELES – BodiMetrics has announced that its circul pro Ring has received clearance from the U.S. Food and Drug Administration as a pulse oximeter. The company says the ring’s patented form factor and LED technology make it uniquely designed to accurately measure blood oxygen level on people with any skin tone. “With the recent scrutiny and clinical results highlighting the inaccuracy of some oximeters in darker pigmented skin, the demand for a higher level of performance is...

BodiMetrics, CIRCUL, Pulse oximeters


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FDA to discuss pulse oximetry concerns 

September 22, 2022HME News Staff

WASHINGTON – The U.S. Food and Drug Administration will hold a virtual meeting on Nov. 1 to discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigments. The CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will also discuss factors that may affect pulse oximetry accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health...

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Nonin Medical marks anniversary

April 27, 2021HME News Staff

MINNEAPOLIS – Nonin Medical is celebrating 35 years in business in the coming months with the largest number of product launches in the company’s history. Over the past three decades the company has introduced dozens of medical monitoring solutions, including the first portable pulse oximeter and first fingertip pulse oximeter, it says. "We are so proud that for the past 35 years, millions of Nonin's devices have generated billions of measurements, improving healthcare outcomes for...

Medical monitoring, Milestone, Nonin Medical, Pulse oximeters


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