SpectraWave HyperVue System Cleared for Coronary Artery Disease

The FDA has granted 510(k) marketing clearance to SpectraWave’s HyperVue system, an intravascular imaging catheter for coronary artery disease.

The system includes near infrared spectroscopy, a noninvasive imaging technique that uses the near infrared region of the electromagnetic spectrum.

The company describes the system as a “catheter with an artificial intelligence-powered user experience” for use during coronary stenting procedures.