QRS Diagnostic Secures 510K Approval for its New EKGCard™ Device
EKGCard, the worldÂ’s smallest and lightest 12-channel electrocardiograph device available in the medical device market today, is ideal for use by physicians and nurses on PDAs
MINNEAPOLIS (PRWEB) June 24, 2003 -
Based medical devices contained entirely in computer cards, announces that the Food and Drug Administration (FDA) has issued 510K approval for QRS to market its new EKGCard™ diagnostic electrocardiograph. It is the world’s smallest and lightest 12-channel electrocardiograph device available in the medical device market today. The new EKGCard measures 2.1 inches x 5.5 inches x 1.0 inch and weighs only 3.2 ounces. It is ideal for physicians to use on Personal Digital Assistants (PDAs).
“We designed our new EKGCard to further leverage and support physicians’ increasing adoption of PDAs for use at the point-of-care,” says Spencer Lien, chief executive officer, QRS Diagnostic. “With our patented technology, our new EKGCard turns standard PDAs into handheld diagnostic instruments and advances our growing line of affordable, upgradeable, and mobile PC Card medical devices.”
“The new EKGCard from QRS is the ultimate combination of quality, ease-of-use, portability and affordability,” says Jeffrey K. Pearson, D. O., medical director of Medicine-in-Motion, a family practice and sports medicine clinic in San Marcos, Calif.
The new EKGCard from QRS Diagnostic utilizes the companyÂ’s patented PC Card technology to build the intelligence of electrocardiography data acquisition entirely into a Type II (PCMCIA) PC Card. Also, with the new device, the electrode leads connect directly to the PC Card itself, thereby eliminating the need for a separate cable between the device and the leads. By simply sliding EKGCard into the PC Card slot of an off-the-shelf PDA, a physician or nurse instantly has a light-weight, portable, and full-function 12-channel diagnostic device.
The company’s current software-based electrocardiograph device connects to computers via USB and serial ports. QRS Diagnostic continues to sell the device worldwide under a new product name, Universal ECG™, primarily for use with notebook, laptop and desktop PCs.
Founded in 1994, QRS Diagnostic, Plymouth, Minn., uses innovative software technology to design and develop FDA-approved medical devices that simplify and reduce the costs of diagnostic testing and patient monitoring. With our patented computer card technology platform, QRS turns PDAs, laptops and handheld PCs into modular, upgradeable and portable medical devices and streamlines the collection and communication of precise physiological data. We enable primary care physicians to cost-effectively practice high-tech medicine while delivering the accuracy that specialists and hospitals demand. The affordability, durability and mobility of QRS devices also advance wireless patient monitoring for disease management, home healthcare and personal health management. For more information on QRS, please visit www. QRSdiagnostic. com.
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