Arterys Cardio AI
Arterys
One of the earliest cloud-based deep learning imaging clearances. Automates ventricular segmentation and function quantification on cardiac MRI.
At A Glance
- Manufacturer
- Arterys
- Medical specialty
- Radiology
- Clearance route
- 510(k)
- Year authorized
- 2017
- Modality
- Cardiac MRI
- Role in workflow
- Quantification
Arterys mattered less for what it measured than for where it ran. A cloud-based inference model reviewed as a medical device raised the questions the field is still working through: how a device is versioned when the algorithm can change server-side, and what "the cleared device" means when the binary is not on the customer's premises.
Where It Is Used
- Ventricular volume and ejection fraction quantification
- Cardiac MRI post-processing
- Serial function comparison
Limitations Worth Knowing
Automated contouring still requires review and correction, and quantification tools inherit the acquisition's problems. Poor gating, arrhythmia, and off-axis planning degrade output in ways the numbers themselves do not reveal.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.