CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT System for Upper Extremities
Warrington, Penn. - May 8, 2017 - CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT Imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position.
The InReach is an ultra-compact CT scanner that provides high-contrast 3D datasets of the bony anatomy, which could potentially replace radiographs as a first line of diagnosis.
The InReach is ideal for the point-of-care because of its small footprint, its self-shielded design, and standard power requirements. Point-of-care 3D imaging allows for faster diagnosis and more accurate treatment plans.
"The InReach will revolutionize the speed and accuracy of assessment of upper extremity conditions that specialists have traditionally found challenging to diagnose with plain X-Ray, such as scaphoid fractures," said CurveBeam President & CEO Arun Singh. "The InReach continues the company's mission to elevate advanced diagnostic imaging capabilities to enhance orthopedic care."
The InReach is designed with patient comfort in mind. Patients' hand, wrist or elbow is positioned in a height-adjustable bore while in standing or sitting position. The unit can also accommodate non-weight bearing, lower limb imaging. Scan times are less than 30 seconds.
The InReach device is supplemented by CubeVue, CurveBeam's custom visualization software. CubeVue gives orthopedic specialists unprecedented access to multi-planar slices and vivid 3D renderings of the anatomy previously not easily accessible to specialists. CubeVue's Insta-X feature provides Digitally Reconstructed Radiographs, potentially eliminating the need for radiographic exams altogether.
The InReach is the second extremity CT imaging system CubeVue has introduced to the market.
CurveBeam is the leader in Weight-Bearing extremity CT imaging, starting with the introduction of its pioneer product, the pedCAT, in 2012. The pedCAT is the only CT system that allows for bilateral, true weight bearing imaging of the lower extremities. Since 2012, the pedCAT has been integrated into leading foot & ankle orthopedic and podiatric practices around the world.
CurveBeam is currently developing its next generation multi-extremity device, the LineUP, which will provide bilateral Weight-Bearing images of the knees & feet, as well as hand, wrist & elbow. CurveBeam anticipates the LineUP will be submitted for FDA review by July, 2017.
CurveBeam Announces the First pedCAT Installation at an Accredited College of Podiatric Medicine
Warrington, PA – August 15, 2016 – CurveBeam is proud to announce the installation of a pedCAT cone beam CT imaging system at Kent State University College of Podiatric Medicine.
Kent State is the first member of the American Association of Colleges of Podiatric Medicine to acquire weight bearing CT imaging technology.
“Kent State University is proud to be the first facility in the Northeast Ohio region to provide this ‘state- of-the-art” imaging modality,” said Dr. Allan Boike, Dean & Professor of Foot & Ankle Surgery at KSUCPM. “The CurveBeam pedCAT will allow the college to improve the foot and ankle health of the community while providing the highest quality education for our students and research opportunities for our faculty and residents.” Read More
Exclusive Video From The First PedCat Scientific User's Meeting in Berlin
The first PedCAT Scientific User’s Meeting was recently held at the 2016 Foot International (EFAS, DAF, I-FAB) in Berlin. The meeting, which focused on the weight-bearing cone beam CT (WBCT), was unique in that both researchers and orthopaedic surgeons gathered to discuss this new type of technology, along with the applications and challenges it presents. Watch the video.
New Technology is Giving Practitioners a 3D View of the Foot in High Heels
Orthopedic surgeons at the Royal National Orthopaedic Hospital in London, UK, have been using a 3D computed tomography (CT) scanner that has a lower radiation dose than traditional CT to assess the ankle and foot while patients are weight bearing and in some cases wearing shoes. They routinely use the 3D scanner to assess patients with flat feet or arthritis to assess deformity and monitor the success of surgery. They also scan patients considering hallux valgus surgery, to look for arthritis in the toe. Read More
CurveBeam receives FDA 510(k) clearance for the Inreach system.
China receives China Food & Drug Administration clearance for the pedCAT system.
CurveBeam receives CE Mark and Health Canada clearance for pedCAT system.
pedCAT recognized as one of 2012's Top 10 Innovations in Podiatry by Podiatry Today magazine.
CurveBeam receives ISO 9001 and ISO 13485 certifications.
CurveBeam receives clearance from the U.S. Food & Drug Administration for the pedCAT system.