British diagnostics technology developer Creavo Medical has obtained CE mark to launch its first device, Vitalscan in Europe.
Creavo’s Vitalscan is a battery powered and portable medical device that can be used in a routine and acute hospital setting while retaining accuracy and efficacy of the older technology SQUID devices.
Using advanced quantum principles, the device measures, displays and stores 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 3-5 minute RULE OUT test gives results on site with very high Negative Predictive Value aiding the healthcare professionals for the chest pain triage process without having to wait for inconclusive lab results.
Creavo Medical Technologies’ Medical Advisory Board chairperson Dr Richard Charles said: “There is compelling early evidence that Magnetocardiography (MCG) as utilised in Vitalscan, can quickly and accurately rule out suspected heart attack in emergency chest pain patients, rapidly relieving both patient anxiety and health care costs.
“The development of Vitalscan opens an exciting new chapter in understanding and managing heart disease.”
The company will now conduct a largescale, multi-centre clinical trial of the device at four major UK sites.
Previously held small sets of demonstrated efficacy of Vitalscan to improve the current triage process for patients admitted to emergency departments with chest pain.