Heart Health, Inc. Researches Predicate Devices to Accelerate FDA Approval of Heart Health Monitor
Posted on: Thursday, 3 April 2008, 09:01 CDT
Heart Health, Inc. (OTCPK: HHEA) is pleased to announce that the Company is currently researching similar products to receive approval of its Heart Health Monitor (HHM). Selection of a similar product, known as "Predicate Device," will enable the Company to proceed in filing its 510(k) to the FDA, which will allow Heart Health to begin marketing the HHM to the public.
A 510(k) is a premarket submission made to the FDA to demonstrate that a device to be marketed is substantially equivalent to an existing legally marketed device in the U.S. Submitters must compare their device to one or more similar legally marketed devices and make and support their "substantial equivalency" claims. A submitter's product may be marketed after 510(k) clearance is granted. After Heart Health selects a similar product, the product will be referenced in its FDA filing.
"We have begun researching similar products to the HHM and expect to select a device shortly so that we can begin the filing for the FDA 510(k). Finding a predicate device will not only speed up the process of getting the HHM approved and to the market sooner, but it will save the Company time and money," stated Michael Kron, Chairman and CEO of Heart Health, Inc.
The Company recently announced it is enhancing its Heart Health Monitor with a USB flash drive and Blue Tooth capability. The Company is currently working with Systems Arts Holding, LLC to produce a prototype of the enhanced Heart Health Monitor under the current consulting agreement between the companies.
About Heart Health, Inc.:
Heart Health, Inc. is a holding company 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.
To automatically receive instant updates, press releases, and other information on this and other Big Apple Consulting USA companies, please visit www.bigappleconsulting.com/compro.php and download your FREE copy of Big Apple ComPro.
Contacts: Heart Health, Inc. Investor Relations 1 866 THE APPL(E)
SOURCE: Heart Health Inc.
Source: MARKET WIRE
Related Articles
- Emergency Filtration Products Submits 510(K) Pre-Market Notification to FDA for NanoMask
- Increased Demand for Wireless Systems Bolsters North American Cardiac Monitoring and Diagnostic Services Markets Growth
- Organic Food and Beverages, Food Intolerance Products, Slimming Products and Fortified/Functional Food and Beverages Are Featured Inside 'the World Market for Health and Wellness Products Report'
- Better heart device safety tracking needed: doctors
- US group urges better heart device safety tracking
- FDA calls in expertise on heart device safety: report
- CAS Medical Systems, Inc. Announces 510(K) FDA Marketing Clearance for Its Near-Infrared Spectroscopy Brain Oximeter
- CORRECTION: Remotes Keep Tab on Heart Devices
- FDA knew of Guidant heart device failures -NYT
- Medtronic gets OK to sell heart device in Europe
 |
 |
User Comments (0)
RSS Feeds