U.S. FDA 510(K) Clearance

Jan 30, 2023 | New, Technology

Medical imaging technology company Adaptix Limited (Adaptix) has received 510(k) clearance from the U.S. Food and Drug Administration for its first medical imaging product.

Adaptix, based at Oxford University Science Park, is driven by a mission to transform radiology by offering affordable low-dose 3D (‘Digital Tomosynthesis’ or ‘DT’) imaging at the point-of-care. 

The first Adaptix medical product is a Digital Tomosynthesis Orthopedic imaging system.  It is a portable, low-dose imaging system capable of delivering fast, lower-cost, X-ray imaging at the point of patient care. Developed specifically to offer 3D X-ray imaging of hands, elbows and feet at a fraction of the radiation dose and per-study price of traditional CT systems, the system provides clinicians with clearer images than 2D X-ray systems, offering advantages in terms of fewer acquisitions, accelerated patient workflow and enhanced diagnostic accuracy.

Adaptix is already serving veterinary and industrial (Non-Destructive Evaluation) markets using its novel and patent-protected technologies. Receiving the 510(k) clearance is important as it is the first step in Adaptix delivering its mission to transform radiology through provision of innovative truly-portable 3D imaging technologies into healthcare providers. 

Mark Evans, Adaptix’s CEO, stated, “We are delighted to receive the 510(k) clearance which allows this innovative technology, and our first medical product, to be marketed in the world’s largest healthcare market. The team are energized by achieving this milestone, and we look forward to delivering enhanced orthopedic DT imaging systems; a dental DT imaging system; and a chest DT imaging system for Intensive Care and Emergency Department use. We see a future where 3D travels to the patient at the point-of-care throughout hospitals, clinics and primary care transforming patient pathways, improving patient experience, and reducing the cost of care delivery.” 

About Adaptix Limited 

2D X-ray is currently the world’s dominant diagnostic modality due to speed and cost, however, this frequently results in inconclusive reads due to areas of clinical interest being obscured by overlying and underlying tissues. This can lead to diagnostic “misses” and delays, additional referrals for an “over-read”, and excessive and expensive escalation to Computer Tomography (CT) or MRI, as well as potentially unnecessary immobilisation of a limb for a patient awaiting diagnosis.   

Adaptix Limited is transforming radiology through the development of innovative 3D imaging technologies. At the core of their patent portfolio and commercialization strategy is a distributed Flat Panel X-ray Source (FPS) system which has applications across a multitude of global markets that are currently limited to 2D X-ray imaging systems where cost, speed to diagnostic result, location or dose concerns mean CT is not optimal. Adaptix’s central mission is to transform radiology by offering affordable low-dose 3D imaging at the point-of-care and allowing “3D-first” as the standard of care.

This project has been supported by the European Space Agency, as part of an ESA Business Applications project, and by Innovate UK.

Investor Contact: Mark Evans – CEO 

mark.evans@adaptix.com 

Media Contact: Carla Taylor – Group Marketing Manager 

carla.taylor@adaptix.com 

Chris has led a highly successful career overseeing Medtech growth into domestic and international markets, including the Americas, UK, EMEA, and APAC. With more than 25 years of sales and commercial leadership experience, he brings a wealth of expertise to his role as a key member of the Adaptix team. Chris is a highly motivated individual with a strong collaborative focus, dedicated to driving Adaptix towards continued success in the global marketplace

Elaine holds a degree in Mechanical Engineering from the University of Galway in Ireland, where she developed a strong foundation in engineering principles and problem-solving skills. She began her professional career with CRH, a leading international building materials company, where she honed her expertise in procuring and delivering large-scale industrial projects. During her tenure with CRH, Elaine gained invaluable experience working in diverse locations, including Ireland, Ukraine, and Belgium, where she played a crucial role in managing complex projects across different cultures and regulatory environments.

Elaine also holds an MBA from Vlerick Business School in Belgium, which further enhances her strategic thinking and leadership capabilities. She is APM certified, reflecting her commitment to excellence in project management.

Jen Carter, FCCA, is a qualified Accountant with over 14 years’ of experience in finance. Qualifying at Grant Thornton, she obtained audit, tax, and project management experience before joining Adaptix at the start of 2022. Jen has continued to expand her role within Adaptix and became Company Secretary in 2024.

Carla Taylor (ACIM), is a professional marketeer with over 20 years' experience within a wide variety of tech-based companies.

Carla's background spans a number of industries including electronics, ANPR, finance, laser imaging and laser micromachining.

Hannah Lawrence-Lelitte (Assoc. CIPD) has extensive experience of strategic people leadership and leading change initiatives.  Her career has focused on working with organisations who believe that developing their people is the key to business success.

As an Executive Coach and Mentor, she is skilled at working with senior leaders to effect systemic change either by working with them or their team members individually or in groups.

Hannah has a background in Organisational Psychology and Transactional Analysis and holds a BSc in Psychology from the University of Surrey.  Hannah is a qualified HR Professional having achieved a Level 7 certificate in HR Management from the CIPD.  She is also a member of the EMCC (European Mentoring and Coaching Council).

Martin Stofanko has a PhD in Immunology and MSc in Applied Genetics from University of Birmingham. Following Postdoctoral work at University of Cambridge he moved into industry in Brazil developing genetic tests for their low budget public healthcare system.

He is experienced in defining, executing and writing up quality assurance and technical documentations for IVDs and up to class IIa sterile MDs in the UK, Brazil and Germany. He has lead validation, external testing and transfer to manufacturing activities within company and outsourced abroad. He has established and extended ISO 13485 QMS from D&D to manufacturing, sales and distribution.

John has 30+ Years industry experience with a comprehensive background within Global Roles in Semiconductor, Electronics and Medical Device Industries.

Areas of expertise include, Start Up Operations, Programme and Performance Management, New Product Introduction and Product Outsource/Transfer.

Conrad Dirckx has a BA in Computer Science and PhD in MRI Imaging from Cambridge University as well as a master’s degree from the Ecole Centrale Paris in real-time computing. He has worked for GE Healthcare in their workstation, vascular x-ray and MRI business units and prior to joining Adaptix, spent 11 years working for Siemens in their molecular imaging division leading development projects for cardiology, neurology and oncology software products.

He is an APMP certified project manager who helped to pioneer the transition to lean/agile software development within Siemens MI.

Andy graduated with an Engineering Masters and boxing Blue from Oxford University, then gained Chartered Engineer status as a project manager while working for the Ministry of Defence. On the MOD Fast Stream, Andy gained corporate and leadership experience in a variety of strategic roles as well as leading counter terrorism teams in Iraq. Andy was awarded the Iraq medal and formally commended for changing the Coalition Forces campaign strategy.

Andy then went into leadership consulting & coaching (clients now diplomats & in No.10) and also moved into the commercial sector founding a film & TV company, raising finance and building relationships with the major studios. While he got the companies up and running Andy secured acting roles in Coronation Street and Emmerdale to help pay the bills.

Steve Wells spent 12 years developing medical devices for Siemens Molecular Imaging before joining Adaptix.

He has a PhD in Neuroscience, MSc in Medical Physics and a Natural Sciences degree from Cambridge. Prior to Siemens he worked as a software engineer on various commercial science projects.

Dr Siân Phillips MB,BCh MRCP FRCR is an experienced Consultant Radiologist based in South Wales.
She gained her undergraduate and postgraduate medical training in Wales. She has held several leadership roles during her career, including Associate Dean and Head of School at Health Education
and Improvement Wales; chair of Medical Imaging Sub-Committee and Imaging Essential Services Group, advising Welsh Government; and Clinical Director. As part of her active involvement in teaching and training, she has been involved in developing undergraduate curricula, been an FRCR examiner at the Royal College of Radiologists (RCR), and was instrumental in establishing and developing the National Imaging Academy, Wales. As a Fellow of the Royal College of Radiologists, she plays an active role in RCR activity.
Siân has extensive experience with Digital Tomosynthesis imaging in the general clinical setting. Her service was the first clinical department in the UK, second in Europe to introduce this innovative
technology. Her experiences with digital tomosynthesis she has shared widely, presenting at international conferences worldwide. She has sat on the Medical Advisory Board of GE Healthcare and acted as Medical Advisor to Adaptix for several years.

Adrian Crockett, BAcc, FCMA is a chartered management accountant who previously held the CFO position at Ocean Harvest Technology PLC where he helped raise £6m via an IPO, Thruvision PLC where he managed significant revenue growth towards £10m and at Venture Life PLC, an AIM listed consumer healthcare company where he was involved in the M&A of a number of businesses, participated in equity capital raises of over £25m and a revolving debt facility of similar with major UK & US banks. Before this he held senior financial management roles at Abbott Diabetes Care Ltd, a division of the US Healthcare company, Abbott, GSK & Novartis.

Sarah Small BSc, ACA is a Chartered Accountant with over 20 years’ experience of leading financial functions, including C-level experience within an AIM listed company.

Sarah has worked across a various number of industry sectors including digital marketing, retail, entertainment, education and construction. Sarah has a mathematics degree from Warwick University.