FDA Approval for Auris' Robotic Endoscopy Platform

Knobbe Martens
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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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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