39 results
424B3
MDAI
Spectral AI Inc - Ordinary Shares
23 Apr 24
Prospectus supplement
6:10am
to pursue the PMA regulatory route should our De Novo request be denied.
In order to sell our device in member states of the European Union (“EU … by the Commission during this period. The relationship between the UK and the European Union in relation to certain aspects of data protection law remains unclear
424B3
MDAI
Spectral AI Inc - Ordinary Shares
23 Apr 24
Prospectus supplement
6:08am
to pursue the PMA regulatory route should our De Novo request be denied.
In order to sell our device in member states of the European Union (“EU … by the Commission during this period. The relationship between the UK and the European Union in relation to certain aspects of data protection law remains unclear
424B3
MDAI
Spectral AI Inc - Ordinary Shares
19 Apr 24
Prospectus supplement
1:57pm
to sell our device in member states of the European Union (“EU”), the device must also comply with the general safety and performance requirements of the EU … in the European Union.”
In the United Kingdom (“UK”), post-Brexit, medical devices are regulated under the Medical Devices Regulations 2002 (“MDR 2002”), which
8-K
EX-99.1
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22 Mar 24
Standby Equity Purchase Agreement
4:00pm
424B3
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1 Feb 24
Prospectus supplement
4:42pm
424B3
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2 Jan 24
Prospectus supplement
4:30pm
8-K
EX-10.1
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27 Dec 23
Entry into a Material Definitive Agreement
8:31am
425
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31 Aug 23
Business combination disclosure
4:15pm
424B3
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11 Aug 23
Prospectus supplement
7:35pm