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Mar 19, 2021Received FDA IDE Approval for Pivotal Study of C-Scan®
Mar 15, 2021Company expects to commence U.S. pivotal trial in late 2021- Aug 6, 2020IDE submission to the FDA for C-Scan® planned for the end of 2020; Initiation of a U.S. pivotal study planned for 2021
- May 27, 2020Strengthened balance sheet through a total of $16.3 million in registered direct offerings and a private placement of ordinary shares in the first half of 2020
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Mar 6, 2020Company planning to initiate a U.S. pivotal study of the C-Scan System in late 2020
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Dec 30, 2019Advancing towards IDE submission to the FDA, targeting initiation of U.S. pivotal study in late 2020
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Dec 20, 2019
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Nov 6, 2019Successfully launched U.S. pilot study and reported positive final results from post-CE approval study of the C-Scan® System
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Aug 19, 2019GE Healthcare facility in Chicago to support clinical investigation needs of the C-Scan® System in the U.S.
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Aug 7, 2019Reported positive final results from post-CE approval study of the C-Scan® System
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Jun 3, 2019Mr. Belkar Brings More Than 20 Years of Global Medical Device Experience, Including at Medtronic and Mazor Robotics
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May 13, 2019Initiates U.S. pilot study of C-Scan® at NYU School of Medicine and Mayo Clinic
