Aug 29 2019
AVRA Medical Robotics, Inc. (the “Company”), an emerging growth company that is in the process of building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software; announced today that its regulatory and management teams met with the Food and Drug Administration (FDA) on August 12th.
The Company’s robot arm has already won approval in the EU and received the CE mark. The Company has begun implementing a quality and regulatory system that will serve as the foundation for US, Canadian, European, Australian, Japanese, and Brazilian market access for AVRA’s modern medical robotic system – a ground-breaking approach to medical robotics. The Medical Device Single Audit Program (MDSAP), which the Company is employing, is a single inspection that, when completed, is expected to support market access to the six most important medical device marketplaces.
Barry F. Cohen, Chairman and Chief Executive Officer of the Company, said:
We were pleased to have a foundational dialogue with the FDA on August 12th 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. 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.”
Source: https://www.avramedicalrobotics.com