FDA clears Masimo's Pronto-7 haemoglobin testing device
This article was originally published in Clinica
Executive Summary
Masimo's Pronto-7, a handheld, noninvasive device for point-of-care haemoglobin testing, has received 510(k) clearance from the US FDA. The palm-sized device is useful in patients who do not need continuous haemoglobin monitoring, but could benefit from immediate spot-testing, Masimo (Irvine, California) says. It could also allow more patients to be assessed and treated for anaemia compared with traditional testing, which involves taking a blood sample and sending it to a laboratory. The company launched the device last week outside the US (www.clinica.co.uk, 24 June 2010). Pronto-7 measures 13cm x 7.2cm x 2.5cm, weighs 296g, and provides results in less than a minute.