All posts by Rebecca Anderson

Creavo Medical Technologies secures U.S. FDA 510(k)

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 2010[1].  75% of these patients[2] 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.”

ENDS

Contact: Rachael Harper – +44 (0) 7850 211 960

Notes to editors

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/

[1] National Ambulatory Medical Care Survey: 2010

[2] Backus et al. 2011; Rohacek et al. 2012; Six et al. 2012; Backus et al. 2013

 

Ian Watson joins the team

Ian Watson has joined the technical department here at Quantum Imaging as a Lead Electronics Engineer.  Having previously held roles at Ferranti, Thomson Sonar Systems, Ericsson, Marconi systems and Power Energy Solutions, Ian brings over 15 years’ experience working within Electronics Engineering.

His expertise include low noise analogue; Multi-layer PCB design; CPLDs and FPGA designs in VHDL as well as experience adhering to strict design standards across multiple industries such as Intrinsic Safety (ATeX), Functional Safety (IEC 61508), ISO 26262 and Embedded Software – C.

Ian will bring additional expertise into the business to develop and lead electronics development which is essential to the company’s success.

Welcome Ian!

Heart disease in the news

We are really pleased to see the clinical need we know to exist for fast and accurate detection and diagnosis in cardiology being highlighted by the national media. This is why Quantum Imaging is engaged in commercializing innovative, potentially life changing technology; to meet this need and cut diagnosis time to minutes for better patient outcomes.

Click here for more information

Dr Shima Ghasemi Roudsari joins the team

Dr Shima Ghasemi Roudsari has joined the fast expanding team at Quantum Imaging as Core Medical Research Manager. She has recently completed her PhD in Medical Physics at the University of Leeds, under the supervision of Professor Ben Varcoe. With an extensive research background in Magnetocardiography (MCG) for the diagnosis of cardiac conditions, she will apply her skills and expertise to help transform the company as a global leader in medical imaging devices.

Welcome Shima!

Lynda Unitt joins the team

Lynda Unitt has joined the team at Quantum Imaging as Clinical Project Manager. Lynda joins us from Corin Ltd. where she was the Clinical Research Manager setting up and conducting all clinical trials for Clinical, Regulatory and Marketing purposes.

Originally a qualified physiotherapist with 16 years’ experience working in the NHS overlapping with 16 years working within clinical research in both an NHS/Private and Industry setting, Lynda will bring additional expertise into the business to develop and lead the clinical programmes essential to the company’s success.

Welcome Lynda!