Titan Medical Inc (TMDIF)

[jhersh]

Titan medical provides regulatory update on its Enos Robotic Single Access System

January 13 -- Titan Medical (NASDAQ:TMDI) announces that it has received a written response from the FDA to its Request for Information regarding the regulatory requirements applicable to its robotically assisted surgical device (RASD), the Enos Robotic Single Access System.

While the FDAs response to the request does not constitute a classification decision, the regulator has indicated that, based on information provided to the agency, the Enos system is appropriate for classification through the De Novo pathway.
Should the FDA grant the De Novo classification request, the Class II device would be cleared to be marketed.
"During the first quarter of 2021, we plan on further communications with the FDA, including filing a Pre-Submission, with the intent of clarifying any requirements for our planned Investigational Device Exemption studies and any potential impact on previously established timelines and forecasted costs, CEO David McNally said.