Healthcare Industry News:  cardiac imaging 

Devices Radiology Cardiology FDA

 News Release - November 15, 2006

Diagnosoft, Inc. Receives FDA Approval for Cardiac MRI Quantitative Regional Function Software Based on the HARP(R) Technology

LUTHERVILLE, Maryland and PALO ALTO, Calif., Nov. 15 (HSMN NewsFeed) -- Diagnosoft, Inc. recently secured FDA approval for their Diagnosoft HARP product, software that assists physicians in the analysis of magnetic resonance (MR) images by providing quantitative measurements and visualization of regional heart function. Based on exclusively licensed technology from Johns Hopkins University (the technology was developed by the founders at JHU), this product is the first FDA approved software designed for the analysis of tagged MR images. Diagnosoft, Inc. is a privately held company (see www.diagnosoft.com) specializing in image analysis software for assistance in diagnosis, staging, and therapeutic monitoring of cardiovascular diseases.

"Robust image analysis methods applied to so-called "tagged" MR images provide cardiologists and radiologists with a powerful tool for the measurement and visualization of cardiac muscle performance -- that is, regional cardiac function -- at a level that has not been possible before," said Dr. Jerry Prince, PhD, Diagnosoft Founder and Professor at JHU. "Radiologists have been limited to the visual analysis of MR images in order to detect weaknesses or abnormalities in the heart muscles. With the Diagnosoft HARP software, images can now be automatically analyzed to reveal a quantitative measure of function and these measures can be visualized on a standard map designed to help physicians correlate abnormalities with coronary arteries that could be blocked."

Beta versions of Diagnosoft HARP software have already been licensed for research purposes to more than two dozen research-oriented institutions around the world, including Carnegie Mellon University, Johns Hopkins University, Cleveland Clinic, Allegheny General Hospital, Cincinnati Children's Hospital Medical Center, and the University of Pennsylvania School of Medicine. With FDA approval, Diagnosoft HARP is now cleared for clinical applications and can be used by radiologists, cardiologists, and pharmaceutical companies in assisting the diagnosis, staging, and monitoring heart disease as well as in the development of new therapies. Diagnosoft will start selling Diagnosoft HARP Version 1.1 (for clinical applications) in November 2006 (please send inquiries to sales@diagnosoft.com).

Drs. Nael Osman and Jerry Prince, both founders of Diagnosoft, developed the HARP algorithm at Johns Hopkins University, where they are both currently on the faculty and experts in medical image analysis. Dr. Matthias Stuber, also a founder and faculty member at JHU, brings additional expertise in MR imaging to the company.

"I am very excited about our recent FDA approval," said Dr. Nael Osman, "Now, Diagnosoft customers can benefit from the full power of the HARP algorithm. We will now see our technology actually used in clinical medicine to help detect early heart disease in a way that was not possible before. This was my vision when I started Diagnosoft."

About Diagnosoft HARP®

Diagnosoft HARP is a computer assisted tool that displays new diagnostically relevant information about cardiac performance to the clinician. More information should assist in more specific diagnosis using noninvasive imaging methods, which is more efficient for the clinician and safer for the patient. The Diagnosoft HARP algorithm automatically generates cardiac bulls-eye diagrams of myocardial strain, directly and comprehensively visualizing regions of deprived myocardial function and effectively becoming the clinicians "second pair of eyes."

About Diagnosoft, Inc.

Diagnosoft, Inc., based in Maryland and California, is a medical imaging company dedicated to diagnostic decision support by increasing physician productivity and accuracy while helping to improve patient outcome and reduce medical errors. Diagnosoft, Inc. is a leader in the research and development and of computer-aided diagnostic software, an innovative technology that assists cardiologists & radiologists in the earlier detection of cardiac disease and coronary abnormalities. For information, visit http://www.diagnosoft.com or call 866-841-9139 x1972.

NOTE: Diagnosoft® is a registered trademark of Diagnosoft, Inc. HARP® is a registered trademark of Johns Hopkins University. Diagnosoft, Inc. disclaims any proprietary interest in the marks and names of others.

CONTACT: Amr A. Awadallah, President & interim Chief Executive Officer Tel: (866) 841-9139 x1972, Fax: (800) 257-1972, Email: press@diagnosoft.com


Source: Diagnosoft

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