Creavo Medical Technologies secures U.S. FDA 510(k) approval for ground-breaking rule-out scanning device

17 October 2017

Technology has the potential to revolutionise emergency department triage of chest pain patients

Developer of innovative medical diagnostic technology, Creavo Medical Technologies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The move opens the U.S. market for its portable scanning device, Vitalscan, and demonstrates an increasing industry focus on the global challenges hospitals face when it comes to triaging chest pain patients.

Rigorous clinical trials will now start in a number of centres across the U.S. in addition to the multi- centre trial already taking place at four major UK emergency departments.

Chest pain and related symptoms are the second most common cause of emergency department visits in the U.S., accounting for approximately 7 million visits in 20101. 75% of these patients2 will have a non-serious cardiac condition but will still have to go through the time-consuming process currently in place which involves an electrocardiogram (ECG), blood biomarker testing and further follow up investigations.

Vitalscan uses magnetocardiography (MCG) to perform a quick, non-invasive three to five-minute scan at a patient’s bedside. This can help physicians accurately rule-out ischemic heart disease, meaning that patients can then go on to the most appropriate care pathway for their needs rather than go through the current lengthy and resource intensive process.

Steve Parker, CEO, Creavo Medical Technologies said: “This is a major development and brings us closer to realising our overriding objective - to improve patient care and save time and resources for hospitals.

“Engagement with the FDA represents yet another significant achievement in what has been a very successful period for us. In the past year we have received CE mark registration in Europe and our large- scale, multi-centre UK clinical trial is continuing to progress well. We also raised a further $17m (£13.4m) in an oversubscribed funding round, enabling us to continue to build momentum and extend our reach further. We know that the technology has the potential to be a game changer and our ability to go from strength to strength is further evidence of this.”