Hypertension Diagnostics Plans Second CVProfilor 510(k) Submission By July
This article was originally published in The Gray Sheet
Executive Summary
Hypertension Diagnostics, Inc. is conducting additional prospective clinical trials of its CVProfilor DO-2020 cardiovascular profiling instrument to support a second 510(k) submission after an initial submission was deemed inadequate by FDA, the firm says. The filing is expected in the first half of this year.