CE Mark for Vitalcscan device to detect and diagnose chest pain.-Creavo Medical Technologies.
Creavo Medical Technologies (formerly Quantum Imaging), an emerging British company developing diagnostics technology for acute medical settings, announced that its first device, Vitalscan, has received CE mark registration, enabling market launch in Europe. The successful receipt of the CE mark means that the device will now start a largescale, multi-centre clinical trial at four of the UK�s major A&E departments, namely Bristol, Sheffield, � Leicester and Nottingham, followed by a second stage starting at three centres in the United States at Mayo Clinic Rochester, Cincinnati and Baylor Texas.
Early indications from smaller sets of clinical trials indicate that Vitalscan could meet an urgent clinical need for improving the current triage process for patients entering emergency departments with chest pain. The device uses advanced quantum principles to measure, display and store electromagnetic fluctuations caused by heart activity through a simple, non-invasive three to five-minute scan at a patient�s bedside. This scan accurately and quickly rules out significant ischaemic heart disease, such as heart attacks. The device will enable clinical practitioners, who operate in acute medical settings, to �rule out� heart-related problems and prevent healthy patients from having to go through the current lengthy, and costly, chest pain triage process, which includes a variety of diagnostic tests including multiple ECGs and cardiac biomarker blood tests.