Arterys said today that it won 510(k) approval from the FDA for its Cardio DL medical imaging analytics software for cardiac MRI images.
The San Francisco-based company said its software leverages cloud computing and “deep learning” to provide blood flow information based on conventional cardiac MRI images.
“Arterys is committed to broadly accelerate the transformation of data-driven medicine through advanced cloud medical imaging analytics applications while always protecting patient data privacy,” CEO Fabien Beckers said in prepared remarks. “Today’s approval signifies a major regulatory milestone. This application demonstrates the power of deep learning combined with cloud supercomputation to aid physicians in interpreting medical images – eliminating tedious manual tasks carried out on a workstation by accurately automating those processes.”
In late December, the company won CE Mark approval in the European Union for the medical imaging software.
In March 2016, Arterys said that it raised a $12 million Series A round for the MRI-based vascular imaging system. Emergent Medical Partners led the round, joined by GE Ventures, the Stanford-StartX Fund and Norwich Ventures. Existing backers Asset Management Ventures, AME Cloud Ventures and Morado Ventures also participated.
In November last year, the company won 510(k) approval from the FDA for its medical imaging software to be used in clinical settings to quantify cardiac flow. Arterys said that the software is the 1st comprehensive visualization and quantification of cardiac function available to physicians in a clinical setting.