MONTREAL, QUEBEC--(Marketwire - Nov. 24, 2008) - Heart Health, Inc. (PINK SHEETS:HHEL) is pleased to announce that the Company has begun the process to obtain FDA approval for the Heart Health Monitor by engaging the services of QualPro Consulting, LLC. The Company will file a form 510K with the FDA to begin retail distribution in the United States.
QualPro Consulting will create the 510K application for the Heart Health Monitor for submission to the FDA. QualPro Consulting will advise the Company’s Board of Directors on all FDA related and strategic issues that could affect the approval process. QualPro will develop a strategy for the Company to achieve all FDA regulations and requirements for approval to sell the Heart Health Monitor in the United States. The Company anticipates introducing the Heart Health Monitor into major pharmaceutical and cardiovascular product market by the spring of 2009.
“QualPro Consulting is a very experienced and knowledgeable company with a proven track record for successfully leading emerging companies through the FDA process. We look forward to working with them in getting our Heart Health Monitor into the market as quickly as possible,” stated Michael Kron, Chairman and CEO of Heart Health, Inc.
To learn more about Qualpro Consulting, LLC, please click on the following link: http://www.qualprollc.com/index.html
About Heart Health, Inc.:
Heart Health, Inc. is focused on the development and marketing of innovative, cardiovascular medical device products. The Company intends to revolutionize the way in which people monitor the health of their hearts using newly acquired products such as the Heart Health Monitor.
Safe Harbor Act: This release includes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involves risks and uncertainties including, but not limited to, the impact of competitive products, the ability to meet customer demand, the ability to manage growth, acquisitions of technology, equipment, or human resources, the effect of economic business conditions, and the ability to attract and retain skilled personnel. The Company is not obligated to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.