Curvebeam Achieves ISO 13485:2016 & MDSAP certification
WARRINGTON, Penn. - June 25, 2018 - Curvebeam announced the company's ISO 13485 certification has been updated to the latest revision of the standard. The company's quality system is now certified to the ISO 13485:2016 standard, which represents the most recent revision of the widely recognized manufacturing quality standard issued by the international Organization for Standardization (ISO).
In addition to 13485:2016 requirements, this certification covers the requirements of the Therapeutic Goods Admnistration (TGA) of Australia; Brazil's Agencia de Vigilancia Sanitaria (ANVISA); Health Canada; the U.S. Food and Drug Administration (FDA) under the Medical Device Single Audit Program (MDSAP). Read More
CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System
WARRINGTON, Penn. - May 14, 2018 - CurveBeam announced it has received FDA 510(k) clearance for its LineUP Multi-extremity weight bearing CT system.
The compact system enables radiologists and orthopedic specialists to visualize three-dimensional bone detail of the lower extremities while the patient is standing, so anatomy can be assessed while in the "weight bearing" or "load bearing" position. The LineUP can perform bilateral scans of entire legs, from below the heel to above the knee. Accessories permit scanning of the hand, wrist and elbow as well. Read More
Curvebeam Receives Innovative Technology Contract from Vizient, Inc. for pedCAT and InReach Extremity CT Imaging Systems
WARRINGTON, Penn. - April 16, 2018 - CurveBeam announced its pedCAT and InReach systems have received an innovative technology contract from Vizient, Inc. the largest member-driven health care company in the country. The contract was awarded based on a recommendation of pedCAT and InReach for orthopedic extremities by one of Vizient's member-led councils. Innovative technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization's care delivery or business model. Read More
Health Canada Approves CurveBeam's InReach System
March 26, 2018 – Warrington, Penn. – CurveBeam announced the InReach cone beam CT system for orthopedics has been approved by Health Canada regulatory authority for sale in Canada.
The InReach is 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 bony anatomy, which could potentially replace radiographs as a first line of diagnosis. Read More
CurveBeam Announces CE Mark Certification for LineUP and InReach Orthopedic Extremity CT Systems
Warrington, Penn. - April 4, 2018 - CurveBeam announced it has received CE Mark certification for its LineUP and InReach orthopedic extremity CT systems.
The compact systems provide radiology and orthopedic specialists with three-dimensional bone detail of the orthopedic extremities. The systems can be plugged into a standard wall outlet and have minimal shielding requirements, hence they can be placed in locations convenient to the patient. Radiation dose to the patient is also significantly less than a conventional CT scan.
The LineUP system permits the patient to stand during the scan, so anatomy can be assessed while in the “weight bearing” or “load bearing” position. The LineUP can perform bilateral scans of entire legs, from below the heel to above the knee. An adaptive chair permits scanning of the hand, wrist and elbow as well.
Weight bearing CT imaging for body extremities became commercially available in 2012. Since then, lower extremity specialists and radiologists have published numerous journal articles on the value of a three-dimensional weight bearing views for conditions ranging from complex hindfoot misalignment to a routine bunion deformity. Published research also suggests a three-dimensional weight bearing view of the knees could be instrumental in early detection of osteoarthritis.
CurveBeam’s InReach system for hand, wrist and elbow received FDA clearance in 2017. Since then, it has been implemented in several leading hand surgery centers in the United States. Specialists extol the ability to confirm a scaphoid fracture diagnosis or distal radius fracture diagnosis at the point-of-care, among other crucial diagnostic details.
CurveBeam introduced the pedCAT system, which permits bilateral weight bearing scans of the foot and ankle in 2012. The pedCAT has since been implemented in many of the premier foot and ankle orthopedic and podiatric facilities in the United States, Europe, Australia and China.
“The recent CE Mark certification of the LineUP and InReach systems demonstrates CurveBeam’s ambition and commitment to elevating the standard of care in imaging for orthopedics,” CurveBeam President & CEO Arun Singh said. “Worldwide anticipation for the LineUP system has been clamorous, and CurveBeam is confident the LineUP will make an even larger impact than the pedCAT did in understanding of lower extremity conditions.”
“We look forward to working with our partners across Europe to promote the LineUP and InReach systems,” CurveBeam Director of European Operations Guy Long said. “CurveBeam has demonstrated strong commitment to the European markets and we are confident its presence will continue to grow rapidly.”
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 CurveBeam 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 Health Canada clearances for LineUP and InReach systems.
CurveBeam receives ISO 13485:2016 & MDSAP certification
CurveBeam receives FDA 510(k) clearance for the LineUP system.
CurveBeam receives CE Mark clearance for LineUP and InReach systems.
CurveBeam receives Health Canada clearance for the InReach system.
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.