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Auris Health Wins FDA Approval for Monarch Surgical Robot

By Fink Densford | March 23, 2018

Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, won FDA clearance for its Monarch robotic endoscopy platform.

The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in diagnostic and therapeutic bronchoscopic procedures.

Auris touted that the system enables more accurate diagnosis and treatment of small and hard-to-reach nodules in the periphery of the lung.

“Technology has advanced significantly since the development of the earliest robotics platforms used in medicine. The Monarch platform is designed to address the limitations of current technology with the introduction of a new era of flexible robotics. With this FDA clearance, we intend to deliver on the promise of improving patient care, starting with earlier and more accurate diagnosis of pulmonary nodules. We envision additional uses for the technology across future endoscopic clinical indications,” CEO Dr. Moll said in a prepared statement.

The Monarch system is a flexible robotic endoscopic platform that uses a controller-like interface which allows the operating physicians to navigate the robotic endoscope through the periphery of the lung.

The platform combines both computer-assisted navigation based on 3-D models of the patient’s lung anatomy alongside traditional endoscopic views, the company said.

Auris Health Monarch Surgical Robot

“Four hundred fifty people die every day in the United States due to lung cancer. It is the number one cancer killer of both men and women in the world. Lung cancer screening has given us an opportunity to save some of these people by diagnosing the cancer early, while we have a chance to cure it. Despite the benefit, we still are limited by the current technology in making a diagnosis. The development of new advanced technology, like the Monarch platform, could allow us the opportunity to make the diagnosis early, which translates directly to saving lives,” Dr. Michael Simoff of Detroit, Mich.’s Henry Ford Health System said in a press release.

Last August, Auris stealthily raised a massive $280 million in a Series D round of financing, bringing the total raised by the early-stage company to more than $500 million.

The company also turned heads in April 2016 when it bought Hansen Medical, which Dr. Moll co-founded, for $80 million.

Founder Dr. Moll has been an important factor in multiple startups in medical devices, and specifically robotics, including market leader Intuitive Surgical, Mako Surgical, acquired in 2013 for $1.7 billion by Stryker(NYSE:SYK) and Restoration Robotics and its Artas hair restoration platform.

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