The FDA has granted 510(k) clearance to the TaviPilot AI software developed by Caranx Medical, according to company officials.
Pierre Berthet-Rayne, the company’s co-founder and chief technology officer, announced the clearance on LinkedIn.
Nice, France-based Caranx Medical developed its TaviPilot robotic solution for aortic valve replacement. The robot can make an artery puncture and then, based on real-time imaging, control the navigation of the instruments to the heart before delivering the prosthetic aortic valve to a location determined in the pre-operative planning. The procedure is completed under the supervision of the clinician.
Related: Mendaera wins FDA clearance for robotic needle placement device
Clinicians use precise preoperative images from CT scans for the planning. During the procedure, they rely only on fluoroscopy. This enables precise and accurate heart valve positioning and delivery.
Berthet-Rayne said the real-time AI software guides TAVI/TAVR procedures by detecting key anatomy and tracking the valve in real-time. It supports physicians, even with heartbeats and breathing motion, with compatibility with all cardiac imaging systems and principal on-market TAVI valves.
“To our knowledge, based on the public FDA 510(k) database, TaviPilot is the first AI software cleared for real-time tracking of anatomical features during a live procedure under physiological motion in interventional cardiology,” Berthet-Rayne said.
