FDA clears AI-powered intravascular ultrasound imaging platform
The U.S. Food and Drug Administration has cleared a new artificial intelligence-powered intravascular ultrasound imaging system, the product’s developer announced on Wednesday.
San Jose, California-based Evident Vascular says the regulatory win applies to its Guidance System and Evident peripheral imaging catheters. They’re intended for examination of pathology during certain peripheral vascular procedures handled by radiologists and other docs.
Evident says the system is designed to improve the clinician experience by combining high-fidelity imaging, “purpose-built AI,” and simple workflows without disruptions. Features include flush-less plug-and-play catheters, an “intuitive” user interface, and hands-free voice controls.
“FDA clearance marks an important milestone for Evident and the physicians who believed in this platform from our company’s inception,” Howard Rosen, CEO and co-founder of Evident Vascular, said in a statement Nov. 4. “We engineered the entire imaging architecture to deliver the image fidelity physicians need in a system that is both intuitive and easy to use.”
Evident said its system integrates broad frequency bandwidth, advanced transducer design and advanced signal processing. It pairs custom imaging electronics with real-time processing, harnessing NVIDIA accelerated computing. AI is integrated into the imaging system and gathers user data to help improve the experience, according to the company. Evident said it plans to introduce further AI capabilities to further enhance exams and workflows.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.