CareStream Health said yesterday it won FDA 510(k) clearance for its Vue Motion universal viewer system designed for the diagnostic viewing of electrocardiogram waveforms.
The system is designed for clinicians, physicians and cardiologists to view ECG exams for patients with ST segment elevation myocardial infarction and other heart conditions and illnesses, the Rochester, N.Y.-based company said.
“Patients suffering from chest pain can face death or disability if their condition is not assessed and treated immediately. Equipping ER physicians, cardiologists or other specialists with the ability to view ECG waveforms from virtually anywhere in seconds delivers valuable diagnostic information that can enhance patient care. This is especially important for a Stemi case, which is a severe and deadly type of heart attack that is identified by a specific ECG pattern,” worldwide product line manager Ron Muscosky said in a press release.
The new system allows users to simultaneously view and share images and data, as well as use tools such as pan, zoom, line measurement, caliper, gain and speed adjustments, CareStream said.
Last February, the company said it landed 510(k) clearance from the FDA for its new Vue Motion mobile app for Apple and Samsung mobile device platforms.
The app gives physicians mobile access to X-ray exams using Apple’s iPhone 4 and iPad 2 devices, as well as the Galaxy Note and Galaxy S III devices made by Samsung.
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