Adaptix receives 510(k) clearance from the U.S. Food and Drug Administration for its first medical imaging product
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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.
Article adapted from: https://adaptix.com/u-s-fda-510k-clearance-received/