The Orlando-based company said its regulatory and management teams met with the FDA August 12 for what chairman & CEO Barry Cohen called a “foundational dialogue” about the device. Avra said it plans to pursue simultaneous approvals in the U.S., Canada, Europe, Australia, Japan and Brazil for its robot arm under the Medical Device Single Audit Program. The Avra arm already has CE Mark approval in the European Union, the company said.
“We were pleased to have a foundational dialogue with the FDA on August 12 to discuss the unique capabilities of our robotic system, which combines artificial intelligence, machine learning and proprietary software, and is designed initially for the aesthetics market,” Cohen said in prepared remarks. “We expect this meeting is the first of a series where the Avra system and all regulatory requirements will be discussed in ever-increasing specificity. We appreciate this opportunity to meet with the FDA and we intend to work together with the FDA to ensure that all quality and safety requirements are addressed from the earliest stages of development. We believe that this will allow AVRA to prioritize the most meaningful activities, saving company resources and time. We look forward to updating the investment community as we move ahead.”