U.S. FDA 510(k) Submission
06/07/2022 - Uncategorized
FOR IMMEDIATE RELEASE
MEDIA CONTACT: Mark Evans
Oxford Tech Company Adaptix Submits US Regulatory Clearance for Transformational Diagnostic Product
New Medical Imaging Product Delivers Affordable 3D Imaging at the Point-Of-Care
OXFORD, U.K., Jul 06, 2022 – Medical imaging technology company Adaptix Limited (Adaptix) has submitted a 510(k) application to the U.S. Food and Drug Administration for its first medical imaging product (‘NeXt 3D-Ortho’), allowing the company to begin marketing its Point-of-Care 3D orthopedic system in the United States.
Adaptix, based at Oxford University Science Park, has developed novel technologies that allow affordable, low-dose 3D imaging at the Point-of-Care using Digital Tomosynthesis (DT), to provider quicker, more accurate diagnosis possibilities.
2D X-ray is currently the world’s dominant diagnostic modality, but frequently results in inconclusive reads due to areas of clinical interest being obscured by overlying and underlying tissues. This leads 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 the unnecessary immobilisation of a limb for a patient waiting diagnosis.
CT provides a more sensitive 3D image but at a far greater cost in terms of money, time and radiation dosage to the patient. Access to CT is also more limited particularly in some countries or regions, resulting in delayed diagnosis and extended travel by the patient.
Mark Evans, Adaptix’s CEO, stated, “This is the first of many innovations that Adaptix is excited about bringing to medical markets. The U.K. is the country that invented the first clinical CT and MRI scanners, and our new low-cost 3D imaging technology builds on the long-standing U.K. pedigree of innovation in medical imaging. We hope that our patent-protected technology will become even more widely deployed and that one day Adaptix’s technologies will touch the lives of everyone through medical and dental applications.”
There is a drive within healthcare systems towards a new diagnostics model where more facilities will be made available in free standing locations away from main hospital sites, to Regional Diagnostic Centres and even commercial and retail locations. This will support earlier diagnosis, greater convenience to patients and the drive to reduce health inequalities. Adaptix’s low-cost deployable 3D imaging will help change the location of service delivery within and beyond the hospital environment, and meet diagnostic needs faster and at a lower cost.
Adaptix already has active customers in the veterinary market with a low dose
affordable 3D imaging system that is used by clinicians in first opinion practices. The orthopedic system will be offered to clinicians and payers on the ‘Pay-per-Study’ model accepted in the veterinary market. Like the veterinary system, the orthopedic system can run from a single-phase domestic power supply and requiring minimal radiation protection measures, further reducing the total cost to payers.
This is the first step in Adaptix’s mission to transform medical radiology by supplying affordable low-dose Point-of-Care 3D imaging to replace 2D X-ray and to do so
using a non-standard business model. Further unmet clinical needs in the dental market (intraoral 3D) and hospital market (a portable 3D chest imaging system for Intensive Care Units, Emergency Departments and Primary Care applications) will be met by later products.
About Adaptix Limited
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.
The first of Adaptix’s medical offerings, the NeXt 3D-Ortho, enables fast, low-cost 3D imaging from a stationary source at a significantly reduced radiation dose and much lower cost than CT systems. Based in Oxford, England, Adaptix has fostered strategic partnerships in academic, medical research, and technology in support of their goal to make advanced 3D tomosynthesis more widely available to healthcare providers and their patients throughout the world. For further information, visit www.adaptix.com.
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