Feb 11 2010
Cambridge Heart, Inc. (OTCBB- CAMH
- News),
today announced that the Company has completed the development phase of
its Microvolt T-wave Alternans (MTWA) OEM Module, and has submitted a
510(k) application for regulatory approval with the U.S. Food and Drug
Administration (FDA). The module is the centerpiece of the Company’s new
business model that involves partnering with leading stress test
equipment manufacturers to broaden the distribution and use of MTWA
technology.
“We are very pleased with our progress and pace in achieving this
important milestone”
“We are very pleased with our progress and pace in achieving this
important milestone,” said Ali Haghighi-Mood, Cambridge Heart’s
President and CEO. “With the completion of the development work and our
FDA regulatory submission, we are one step closer to making our
Microvolt T-wave Alternans technology available to more physicians and
their patients.”
The MTWA test, administered in much the same way as a stress test, is a
non-invasive diagnostic tool that can identify the presence of a subtle
alternating pattern in the ECG which has been shown to be a significant
risk factor for sudden cardiac arrest.
SOURCE Cambridge Heart, Inc.
Novel AI ECG model outperforms standard triage for acute coronary occlusion