Only hospital-grade medical devices need FDA approval. Over-the-counter pulse oximeters, available online for as little as $14.99, use similar technology but are largely unregulated. So ...

The FDA’s draft guidance clarified requirements for pulse oximeters, increasing the number of recommended study participants from a minimum of 10 people to 150, and provided more specifics on ...

Lumerah is a foetal pulse oximeter, measured using an external ... In June 2023, the FDA approved Owlet’s BabySat device which uses a wire-free sock design to house pulse oximetry technology ...

UK digital health company Oxehealth has claimed FDA approval for software that can ... It works the same way as a pulse oximeter, which is widely used in healthcare but must be attached to a ...

New FDA Draft Guidance Raises the Bar on Pulse Oximeter Accuracy – MethodSense Leads the Way in Compliance, Clinical Validation, and Regulatory Strategy Manufacturers need to understand both the ...

Efforts to fix bias and accuracy problems with pulse oximeters have an uncertain future under the Trump administration. After years of concerns that pulse oximeters may provide less accurate ...