FDA clears Corindus’ automated robotic surgery software

Corindus' CorPath GRX system. (Corindus)

The FDA has approved an automated movement add-on for Corindus Vascular Robotics’ percutaneous coronary intervention (PCI) procedure platform. Corindus sees the software update expanding use of surgical technology CorPath GRX to more complex procedures.

Waltham, Massachusetts-based Corindus developed CorPath GRX to support the delivery and manipulation of guidewires and catheters. The physician manipulates the devices via a control panel that displays what is going on inside the patient using angiographic fluoroscopy. The FDA approval clears the company to give users access to a new feature.

The approval covers software that supports the automated movement of the surgical system. When the joystick is retracted, the guidewire is automatically rotated. Corindus thinks this will cut wiring time and enable surgeons to reach target lesions faster.  

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Securing FDA clearance moves Corindus a small step closer to its ultimate goal of using software to automate and standardize PCI procedures, thereby enabling more patients to receive care currently limited to hospitals with top-tier surgeons.

“FDA clearance of this new software feature marks the first step on our path to full autonomous navigation,” Corindus CEO Mark Toland said in a statement. “Over the next several years, we will focus on automating the techniques of world-class physicians to make them available to every hospital with a vascular robotic program.”

Corindus is some way from realizing this goal. At the last count, the company had installed 33 CorPath GRX systems. That translated to revenues of just shy of $10 million last year. 

Shares in Corindus rose as much as 15% in premarket trading following news of the FDA clearance.