Creavo Medical Technologies secures U.S. FDA 510(k) approval for ground-breaking rule-out scanning device
Date: October 16, 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.”
¹ National Ambulatory Medical Care Survey: 2010 ² Backus et al. 2011; Rohacek et al. 2012; Six et al. 2012; Backus et al. 2013
Contact: Rachael Harper – +44 (0) 7850 211 960
About Creavo Medical Technologies Ltd.
Creavo Medical Technologies Ltd is a UK-based, privately held medical device company that is developing innovative diagnostic techniques. The company was formed in 2014 to bring to market ground-breaking technology developed by Professor Ben Varcoe, Chair of Quantum Information Science at Leeds University. It has facilities in Leeds and Coventry, UK.
Focused on improving front line patient care in acute medical settings, Creavo’s first application of this technology is the Vitalscan – a device that meets an urgent clinical need in global cardiology to help more accurately ‘rule out’ heart-related problems at point of admission to emergency departments.
Vitalscan is a battery-powered, portable medical device that uses advanced quantum principles to measure, display and store electromagnetic fluctuations caused by heart activity. Early indications from smaller sets of clinical trials indicate that the device can help accurately and quickly rule out significant ischaemic heart disease with near 100% accuracy through a simple, non-invasive three to five-minute scan at a patient’s bedside.
For more information about Creavo, please visit: http://www.creavomedtech.com/Back to News Overview