Pronto-7 to Check Hemoglobin Levels Non-Invasively Receives 510(k) Clearance from FDA

California based medical device company Masimo Corporation announced that it has received a 510(k) clearance from the US Food and Drug Administration for its non-invasive device, Pronto-7 for checking total hemoglobin (SpHb), SpO2, pulse rate, and perfusion index. The company revealed that using the device will allow physicians to check hemoglobin levels without the need for invasive procedures such as finger pricking and direct blood sampling. Dr Andrew Schuman, who helped review the device for the FDA, termed the device as a “game changer”.

“Not only does it represent an exciting medical advancement in point-of-care testing, but it also provides pediatricians with a high-tech alternative to painful venipuncture or finger stick blood sampling that, until now, has been the only way to measure hemoglobin levels in our young patients”, Dr Schuman said.



Source-Medindia