HeartVue 6S seeks USA marketing

Pegasus/Heartview LLC has announced that clinical studies of its HeartVue 6S Heart Screening System - which obtained CE Mark Approval in Europe almost two years ago - have been completed according to FDA guidelines, as a pre-marketing condition for release in the USA.

The HeartVue 6S Screening System, use as a screening tool, provides a quick, accurate assessment of patients with suspected coronary artery disease in 1–2 minutes.
The clinical studies included testing 170 patients of various ages, genders, races, weights and health conditions. The results will now be analysed, interpreted and presented to the FDA in the form of a 510K Filing.

01.09.2008

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