Ventripoint Diagnostics Ltd. announce that it has submitted to the US Federal Drug Administration a new 510(k) for clearance for the VMS(TM) heart analysis system for use in Pulmonary Arterial Hypertension (PAH). The company affirms that it has maintained an open dialog with the Agency in preparing the submission and as a result changed the submission from a 'software-only' application, as previously recommended by the Agency and announced by the Company, to a submission with software and hardware descriptions. The Company continues to expect the review process to be completed by the end of the first quarter of 2014.
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