FDA clears next-gen hybrid system for intravascular imaging
Conavi Medical, a Toronto based medtech company, received U.S. Food and Drug Administration (FDA) clearance for a next-generation hybrid imaging system capable of performing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at the same time.
Conavi has carved out its own space in the field of intravascular imaging by developing hybrid systems that save cath labs valuable space by performing two different exams of a patient’s coronary anatomy at once. The company’s original Novasight Hybrid System gained FDA clearance in 2018.
“FDA clearance of our next-generation hybrid imaging system marks a pivotal moment for Conavi as we transition into commercial launch in the United States,” Thomas Looby, CEO of Conavi Medical, said in a statement. “We believe hybrid IVUS-OCT imaging represents the next evolution in intravascular imaging, bringing together IVUS and OCT into a single system to give a complete picture of the vessel … This clearance reflects years of focused work by an exceptional team across engineering, clinical, regulatory, and operations, and would not have been possible without the trust of our clinical investigators, the commitment of our manufacturing and supply partners, and the continued support of our shareholders.”
“Hybrid IVUS-OCT imaging has the potential to meaningfully enhance how we approach complex coronary interventions,” added Megha Prasad, MD, an interventional cardiologist at New York-Presbyterian Hospital familiar with Conavi’s technologies. “The ability to simultaneously evaluate plaque composition, vessel size and stent expansion in a single pullback can support procedural decision-making and workflow efficiency. Technologies like Conavi’s next-generation hybrid system are helping move the field toward more precise, image-guided care, and I look forward to using it regularly in my practice.”
Conavi hopes to start commercializing this next-generation technology and initiate a limited market release in the second half of 2026.
In January, Conavi recalled the catheters associated with the Novasight Hybrid System due to a risk of the sheath becoming detached during use. This was reported in one patient, and the catheter was safely removed without an additional injuries.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.