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Mazor spinal deformity correction software OKd by FDA

April 19, 2017

Mazor Robotics earned an FDA nod for its software that helps surgeons plan spinal deformity corrections and spinal alignment for procedures using the company’s robotic-assisted guidance platform for spine surgery.

The Mazor X Align software joins other modules in the company’s preoperative analytics software suite, Mazor said in a statement. It allows surgeons to produce a three-dimensional spinal alignment plan for individual patients.

The 3D plan models the entire spine and provides a preoperative estimate of how the surgery will affect the patient’s posture, Mazor said.

The company will debut the software in an early release next month. It will follow with a widespread rollout in the second half of the year, according to the statement.

RELATED: Mazor Robotics posts first earnings since Medtronic deal

Mazor made a pair of co-promotion and co-development deals worth up to $50 million with Medtronic last year. At the time, it picked up $11.9 million in return for 4% of its shares. When it launched its Mazor X guidance platform in July, it met a milestone and collected $20 million from the device giant.

The Mazor X system is designed to enhance “predictability and patient benefit, through the combination of analytical tools, multiple-source data, precision guidance, optical tracking, intra-op verification, and connectivity technologies,” Mazor said.

While Intuitive Surgical has enjoyed a sizable head start in the robotic surgery space, Medtronic is working on its own surgical robot, which is “likely” to hit the market next year, according to analysts. Johnson & Johnson and Verily’s Verb Surgical is also developing surgical robotics, as are Hansen Medical and Auris Surgical Robotics, which announced last year that they would merge.


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