CurveBeam AI, Ltd., combines market leading point-of-care diagnostic cone beam CT imaging solutions with artificial intelligence (AI) and deep learning AI (DLAI) expertise to deliver solutions across orthopedics and bone health (fragility fracture prevention).
CurveBeam AI was formed in 2022 when CurveBeam, LLC and StraxCorp Pty Ltd entered into a definitive merger agreement.
CurveBeam AI’s global operations headquarters for product development, Regulatory, manufacturing, and operations including sales, marketing, and customer care will remain in Hatfield, PA, USA. CurveBeam AI’s corporate office in Melbourne, VIC, Australia, will cover AI research & development, corporate finance, and IP functions.
“CurveBeam AI offers proprietary tools to improve patient outcomes,” said CurveBeam AI COO, CTO (CT), & President (US Division). “Weight bearing CT imaging is a core focus, however we also have a steadfast commitment to building the complementary AI software tools that will offer first-to-market solutions for bridging disease care while improving reimbursement access to reduce the barriers to adoption.”
Timeline
July 2024
CurveBeam AI received Special FDA 510(k) clearance for enhanced X-Ray source for HiRiseSeptember 2022
CurveBeam merges with StraxCorp, becoming CurveBeam AI.February 2021
CurveBeam receives Canada Health clearance for the HiRise system.November 2020
CurveBeam receives FDA 510(k) clearance for the HiRise system.October 2020
CurveBeam receives CE Mark clearance for the HiRise system.May 2020
CurveBeam is granted a patent for TALAS, a system for three-dimensional measurement of foot alignment.July 2018
CurveBeam receives Health Canada clearances for LineUP and InReach systems.June 2018
CurveBeam receives ISO 13485:2016 & MDSAP certificationMay 2018
CurveBeam receives FDA 510(k) clearance for the LineUP system.April 2018
CurveBeam receives CE Mark clearance for LineUP and InReach systems.March 2018
CurveBeam receives Health Canada clearance for the InReach system.May 2017
CurveBeam receives FDA 510(k) clearance for the InReach system.June 2015
China receives China Food & Drug Administration clearance for the pedCAT system.February 2013
CurveBeam receives CE Mark and Health Canada clearance for pedCAT system.August 2012
pedCAT recognized as one of 2012's Top 10 Innovations in Podiatry by Podiatry Today magazine.July 2012
CurveBeam receives ISO 9001 and ISO 13485 certifications.April 2012
CurveBeam receives clearance from the U.S. Food & Drug Administration for the pedCAT system.Corporate Governance
Curvebeam AI is ISO 13485:2016 certified.
Curvebeam AI is Medical Device Single Audit Program (MDSAP) certified.
CurveBeam AI reports payments to qualifying physicians and teaching hospitals through the CMS Open Payments program.
