FDA clears Xact's hands-free, robotic needle surgery system

operating room
Xact Robotics previously received a CE mark for the system in abdominal procedures alongside $5 million in a series C funding round in September 2018. (CC0 Creative Commons)

Xact Robotics has received an FDA clearance for its hands-free robotic surgery system, designed for CT-guided percutaneous interventions and procedures.

The system uses image-based surgical planning tools and navigation systems to insert and steer various instruments to the desired location within the body. Xact said the surgical robot can be used in an array of clinical applications and indications such as tissue biopsies, abscess drainage or ablations.

In addition, the system’s relatively small footprint and mobile, cart-based design allow providers to meet different needs and clinical areas, the company said.


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“We are committed to redefining the way the entire medical community utilizes robotics, beginning with interventional radiologists,” Xact’s founder, executive chairman and president, Harel Gadot, said in a statement. “Being the first to introduce a hands-free robotic system, we have the potential to provide significant clinical, technical and economic value while democratizing interventional procedures.”

RELATED: Xact Robotics nets CE mark, $5M for its robot-guided needle surgery system

The system is designed to overcome the challenges of manually steering a fine biopsy needle—avoiding damage to healthy tissue while also accounting for the patient’s movement and breathing, for example. According to the company, the hands-free system is accurate to within 1.5 millimeters. In addition, the planned path of the needle can be adjusted without reinserting the needle or repositioning the patient.

Xact previously received a CE mark for the system in abdominal procedures alongside $5 million in a series C funding round in September 2018.

The company said it plans to launch the system among a select number of U.S. partners and radiology centers, with its formal debut at the Radiological Society of North America conference in Chicago this December. Founded in 2013 with locations in Massachusetts and Israel, Xact’s work is based on research at the Technion – Israel Institute of Technology by Moshe Shoham, the founder of Mazor Robotics, which was fully acquired by Medtronic for $1.6 billion last year.

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