FDA Radiology AI Devices

The Makoto Intravascular Imaging System™ is a medical imaging device that uses near-infrared spectroscopy combined with intravascular ultrasound to examine coronary and peripheral arteries. It helps clinicians detect lipid-core plaques, assess coronary artery lipid burden, and identify patients at risk of cardiac events by providing detailed images and compositional information of blood vessels. The device includes software that automatically identifies vessel borders and guide catheter locations, aiding in precise and efficient vascular assessment during invasive angiographic procedures.