Tag: Pulse oximeters
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...
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...
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...
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...
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...
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...