SpectraWave HyperVue Imaging System Enhancements Cleared by FDA

September 19, 2023—SpectraWave, Inc. announced FDA 510(k) clearance for product enhancements to the HyperVue imaging system. The intravascular imaging system features the company’s next-generation DeepOCT images and near-infrared spectroscopy (NIRS), with state-of-the-art ease of use to support physicians and optimize coronary stenting in the cardiac catheterization lab.

On March 1, 2023, the company announced FDA clearance of its flagship HyperVue system for imaging of coronary arteries. It is intended for use in patients who are candidates for transluminal interventional procedures.

The newly cleared product enhancements include contrast-free saline imaging, artificial intelligence (AI) algorithms to support the identification of key clinical structures of calcium and external elastic lamina, and hands-free angiographic coregistration. These features add to the existing HyperVue tool kit, which includes AI-enabled lipid, lumen, stent, and side branch detection, as well as the no-flush prep Starlight imaging catheter designed for efficient setup and image acquisition in complex lesions.

“Intravascular imaging is essential to optimize patient outcomes,” commented Richard A. Shlofmitz, MD, in the company’s press release. “I use intravascular imaging in all my coronary stenting patients, and I’m delighted to see SpectraWave enter the arena and push the limits of these technologies to help us better care for our patients.”

Dr. Shlofmitz, Chairman of Cardiology of the St. Francis Hospital and Heart Center in Roslyn, New York, continued, “The combination of DeepOCT and NIRS is ground-breaking and provides important clinical information that was previously unavailable. With the recent updates that allow for contrast-free saline imaging and support image review with AI, this product will provide significant value to both experienced physicians and those just beginning to embrace imaging.”