Sounds like there is a lot more to it than I imagined for the...

Sounds like there is a lot more to it than I imagined for the new De Novo submission.

”A new look In-Vivage device with enhanced software interface was completed in the quarter.”

”The company contracted a US based manufacturer to assist with the design, manufacture and testing of a sterile sheath for the new In-Vivage probe on an accelerated timeline. Completion of design changes to support the updated In-Vivage have also been completed leading to a significantly more user-friendly system. Enhanced changes to the In-Vivage probe, its sheath and the software interface take into account the feedback received by the FDA earlier in 2023, to significantly de-risk its De Novo submission. These learnings have been integrated into the company’s other device development”

Given the above, no wonder the submission is taking time. The company uses language like “submission within the shortest possible time” but unfortunately does not provide an actual estimate of timeframe, so we don’t know if we are 6 weeks away or 6 months away. Obviously the key positive is that this experience should help streamline future submissions.

For the company to be bringing on BDMs in the USA one would have to imagine they feel they aren’t too far away from having a product they can actually sell…