Tag: Pulse oximeters
Nonin Medical marks 40 years in business
March 26, 2026HME News Staff
MINNEAPOLIS – Nonin Medical is celebrating its 40th anniversary in 2026, marking four decades of offering patient monitoring solutions, including the first pulse oximeter, to clinicians, sleep specialists, home care providers, respiratory therapists, and OEM customers worldwide. The company was founded in 1986 by engineer and entrepreneur Phil Isaacson. “From the very beginning, our goal was to give clinicians data they could depend on without question,” said Isaacson. “Trust...
Danaher to acquire Masimo for $9.9B
February 18, 2026HME News Staff
WASHINGTON – Danaher Corporation, a global science and technology company, has entered into a definitive agreement to acquire Masimo Corporation, a specialty diagnostics provider of pulse oximetry and other patient monitoring solutions, primarily in acute care settings.
Under the terms of the agreement, Danaher will acquire all of the outstanding shares of Masimo common stock for $180 per share in cash, or a total enterprise value of approximately $9.9 billion, including...
Owlet secures partnership with mom-and-baby focused DME provider 1 Natural Way
December 22, 2025HME News Staff
LEHI, Utah – Owlet will now provide BabySat, its prescription pulse oximeter that’s cleared by the U.S. Food and Drug Administration (FDA), on 1NaturalWay.com. Together, Owlet and 1 Natural Way aim to reach more families who could benefit from clinically validated, prescription-supported home monitoring. "We are thrilled to expand the availability of Owlet products via 1 Natural Way, as a leader in the parenting...
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...
FDA issues draft guidance on pulse oximeters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WASHINGTON – The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a range of skin pigmentations.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...
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...