Bioheart has secured non-exclusive distribution rights to RTX Healthcare’s Bioheart 3370 Heart Failure Monitor, an interactive at-home intelligent device designed to for patients with heart failure.
The device, manufactured by RTX of Noerresundby, Denmark, has FDA 510(k) market clearance for marketing in the U.S. and CE mark approval for marketing in Europe and other countries that follow this mark.
The Sunrise, Fla.-based Bioheart is planning to begin immediate commercial distribution.
Bioheart 3370 Heart Failure Monitor tracks patients through personalized daily interactions and questions, while collecting vital signs and transmitting the information directly into a database. It also is uniquely available in both a wireless configuration and through hook-up to regular telephone lines, according to the company.