1st July 2015
Acuitas Medical receives FDA clearance for fineSA® software
Acuitas Medical Ltd, a developer of analysis software for magnetic resonance imaging (MRI), has received market clearance from the United States Food and Drug Administration (FDA) for its fineSA software. fineSA is a software package that analyzes MRI data and determines the spacing of structural elements within a region of interest at a resolution higher than can be achieved with conventional MRI. This market clearance applies to the assessment of bone structure in the lumbar spine. Spine examinations are the most common application of MRI, with more than 12 million procedures performed annually worldwide.
Commenting on the clearance, Dr John Heinrich, the Chief Executive Officer of Acuitas Medical, said, “We are extremely pleased to have received market clearance from the FDA. This clearance, in combination with the CE mark we received earlier this year, allows us to begin marketing fineSA in two of the largest markets for MRI, the USA and Europe. We believe fineSA can provide structural information in a wide range of applications and we look forward to continuing to work with the FDA to broaden our indications.”
The clearance letter, K150069, can be found on the FDA website.