Heartstream wrapping up clinical study of user-friendly, biphasic external defibrillator.
This article was originally published in The Gray Sheet
Executive Summary
HEARTSTREAM CLINICAL STUDY FOR USER-FRIENDLY BIPHASIC EXTERNAL DEFIBRILLATOR is expected to be completed early this year, the company says. The clinical trial, involving 200 patients at 12 sites, is currently under way and has "very clearly" demonstrated the efficacy of the automatic external defibrillator (AED), Heartstream President and CEO Alan Levy said Jan. 10 at the Hambrecht & Quist life sciences conference in San Francisco. Heartstream plans to file a 510(k) for the defibrillator before the end of this year.