Adaptix secures 510(k) clearance from FDA
We are pleased to announce that medical imaging technology associate company Adaptix Limited (Adaptix) has received 510(k) clearance from the U.S. Food and Drug Administration for its first orthopaedic medical imaging product.
In 2021, Avingtrans invested £4m in Adaptix, for an 11.9% stake in the business and in December 2022 announced a further investment of £2m by means of a Convertible Loan.
The Board of Adaptix has made the following announcement:
Adaptix, based at Oxford University Science Park, has received 510(k) clearance for its first medical imaging product. The first Adaptix medical product is a Digital Tomosynthesis Orthopaedic 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, CEO of Adaptix, commented:
“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 orthopaedic 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.”