- Nano cap PAVmed (PAVM -18.1%) is down on increased volume in response to its disclosure that it will resubmit its U.S. application seeking clearance for its CarpX device for the treatment of carpal tunnel syndrome.
- It previously filed a 510(k) application using a commercially available carpal tunnel release device as a predicate (comparator). The FDA notified the company yesterday that the review team had failed to reach a consensus on the filing within the standard timeframe and recommended that it extend the review period with a resubmission (initiated today). It expects to complete the process in 30- 45 days. If rejected again, an appeal is likely.