Adaptix Limited Files for FDA Clearance of Point-of-Care 3D Imaging System

Adaptix Limited has submitted a 510(k) application to the US Food and Drug Administration for its first medical imaging product, NeXt 3D-Ortho, the company’s point-of-care 3D orthopedic system. 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 and potentially more accurate diagnosis possibilities.

Mark Evans, Adaptix's CEO, stated, "This is the first of many innovations that Adaptix is excited about bringing to medical markets. The UK 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 UK 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 centers 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, according to the company’s statement.