PAVmed down 18% on extended review timeline for CarpX device [Seeking Alpha]
PAVmed Inc. (PAVM)
US:NASDAQ Investor Relations:
ir.pavm.com
Company Research
Source: Seeking Alpha
Nano cap PAVmed ( PAVM ) 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. See all stocks on the move » Now read: Valeritas' V-Go insulin delivery device launched in Australia » Subscribe for full text news in your inbox
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PAVM
News
- Why PAVmed Inc. (PAVM) Dipped More Than Broader Market Today [Yahoo! Finance]Yahoo! Finance
- Lucid Diagnostics to Participate in Fireside Chat at the 23rd Annual Needham Virtual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- PAVmed Inc. (NASDAQ:PAVM) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- PAVmed Full Year 2023 Earnings: EPS Beats Expectations [Yahoo! Finance]Yahoo! Finance
- PAVmed Non-GAAP EPS of -$1.33 beats by $0.47, revenue of $1.05M beats by $0.02M [Seeking Alpha]Seeking Alpha
PAVM
Sec Filings
- 3/25/24 - Form 10-K
- 3/14/24 - Form 8-K
- 3/14/24 - Form 8-K
- PAVM's page on the SEC website