Diagnostics player Creavo Medical picked up a CE mark for its battery-powered, portable scanner to help emergency room staff quickly assess heart problems in patients with chest pain.
The device, Vitalscan, is Coventry, U.K.-based Creavo’s first product. The noninvasive scan takes three to five minutes at a patient’s bedside. It measures electromagnetic fluctuations caused by heart activity to help clinicians rule out ischemic heart conditions, such as heart attacks, according to a statement. The presence of necrotic or ischemic heart cells distorts the data points, the company said. From these data, the device produces a trace and 2-D magnetic field map of the heart.
Vitalscan cuts down on the time and number of tests traditionally required to triage chest pain, the company said. This can entail an assortment of diagnostic tests, such as several ECGs and blood tests for cardiac biomarkers.
“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,” said Dr. Richard Charles, emeritus consultant cardiologist at Liverpool Heart and Chest Hospital and chair of Creavo’s board, in the statement.
With the CE mark under its belt, Creavo will now launch a large, multicenter clinical trial at four major A&E departments at U.K. hospitals—Bristol, Sheffield, Leicester and Nottingham—according to the statement. The company will follow this up with a trial at three U.S. sites, including the Mayo Clinic in Rochester, Minn., and Baylor in Texas.
Vitalscan is not the only device aimed at streamlining triage in the emergency room. Earlier this month, the FDA green-lighted Neural Analytics’ fully portable ultrasound system for the quick and noninvasive diagnosis of brain disorders. The hope is that the battery-powered Lucid System will catch disorders, such as traumatic brain injury, early on when it is most important to act quickly.