US-based Ventripoint Diagnostics has submitted a new 510(k) to the US Food and Drug Administration (FDA) for the clearance of VMS heart analysis system for use in pulmonary arterial hypertension (PAH).
Ventripoint clinical affairs vice-president Jim Bodtke said the company has included in the submission significant additional information concerning the accuracy, reproducibility and clinical use of various imaging approaches in patients with PAH.
"We feel we have appropriately addressed the Agency’s concerns as expressed in their letter of November 8, 2013," Bodtke added.
The company stated that it has maintained an open dialog with the FDA in preparing the submission and as a result changed the submission from a ‘software-only’ application, as previously recommended by the FDA and announced by the company, to a submission with software and hardware descriptions.
Currently, the company anticipates expecting the review process to be completed by the end of the first quarter of 2014.
Ventripoint CEO Dr George Adams said the team did an excellent job re-writing the submission so quickly, which allowed the company to re-submit the 510(k) in record time.
"I would like to thank our consultants as well the Agency for all their assistance," Dr Adams added.