Caranx Medical surgical robot TaviPilot AI software wins FDA clearance

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.

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.

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