Medical technology company Terumo Corporation (TYO:4543), through its division Terumo Interventional Systems (TIS), announced on Friday that it has received 510(k) clearance from the US Food and Drug Administration for its OPUSWAVE Dual Sensor Imaging System.

The accompanying DualView imaging catheter also received FDA clearance.

The OPUSWAVE Imaging System integrates Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) into a single catheter, aiming to enable simultaneous visualisations of coronary artery disease. This technology is designed to enhance the evaluation of lesion morphology during percutaneous coronary intervention procedures.

The DualView catheter features a 150mm maximum pullback length, a 2.6 Fr. imaging profile, 6 Fr. guide compatibility, and a variable pullback speed of up to 40mm per second in dual mode.

The system seeks to allow physicians to improve imaging efficiency and reduce procedural time and costs while maintaining image quality.