FDA Approval for Auris’ Robotic Endoscopy Platform

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform.”

Josh DeFonzo, Auris’ Chief Strategy Officer, noted some challenges with endoscopy and need of better control for endoscopic systems:

Endoscopy requires a lot of skill, but also you’ve got to be very facile in maneuvering a device – a device that’s anywhere from approximately a meter to, in the case of colonoscopy, three meters long.

According to Bloomberg Businessweek, the Monarch Platform, instead of the traditional, antiquated one-handed interface requiring twist and control maneuvers, features robotic arms that doctors can control using a controller that on the surface resembles a game console controller. DeFonzo further stated that “Auris’ system allows for more direct control through a game-like controller.”

Dr. Fred Moll, CEO of Auris Health, Inc., said in an interview that Auris is currently focused on lung cancer for two reasons: (1) lung cancer is the deadliest cancer in the world; (2) lung provides a perfect “proving ground” because it comprises a complex network of tunnels.  According to Dr. Moll, the Monarch not only can navigate nimbly through the lung, but also can improve over time thanks to its navigation software.

Auris Health, Inc. is led by CEO Dr. Fred Moll, also known for his Da Vinci Surgical System, a top-selling surgical robot used in laparoscopic surgeries. According to DeFonzo, the company anticipates a limited launch of the Monarch across the U.S. and commencement of its pilot studies later this year.

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.

Auris has recently raised $280 million in a Series D round of financing, and also acquired Hansen Medical, which Dr. Moll cofounded, back in 2016.

Sean Kim
Sean S. Kim is an associate in the firm's Orange County office. He practices intellectual property law with an emphasis on patent prosecution, due diligence, and portfolio management in the mechanical and medical device practice areas. Sean received his Bachelor's Degree in General Engineering from Harvey Mudd College and attended University of Illinois College of Law. During law school, Sean served as president of Asian American Law Students Association and as a production editor of Journal of Law, Technology & Policy. Prior to law school, he worked for a start-up company that designed and manufactured fuel cells and wafer manufacturing equipment company.
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