Nonin Medical has received the US Food and Drug Administration (FDA) 510(k) approval for an expanded indication of its Onyx Vantage 9590 professional fingertip pulse oximeter.
The expanded indication, in addition to previous indication for fingertips, allows clinicians to use Onyx Vantage 9590 on fingers, thumbs or toes.
The Onyx Vantage captures oxygen saturation (SpO2) and pulse rate measurements even in the presence of low perfusion and dark skin pigmentation.
Nonin Medical sales vice president Kevin McGowan said the expanded indication gives clinicians with flexibility to obtain readings on a wide range of patients from pediatrics through adult whose digit diameters range from 0.3 inches to 1.0 inches.
"That’s because, regardless of which digit they use, they can be assured that they are getting accurate readings for improved decision making that may lead to earlier intervention and better outcomes," McGowan added.