Formus Labs today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Formus Hip as the first “automated radiological image processing software” for hip replacement pre-op planning.
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Joining the Formus Labs team in newly created roles are a dedicated Product Lead, Computer Vision Engineer, and Office Administrator, bringing the total team size to 10 full-time employees.
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Welcoming new board member Sabeen Shaikh
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The Formus team spent more than 720 man-hours working on the submission which required comprehensive information on all areas of the product, from software design and verification to risk management and user validation.
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This recent case study, successfully completed alongside Dr. Paul Monk and the Auckland Bioengineering Institute (ABI), showcases the versatility and effectiveness of the Formus platform.
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We are coming to the end of a year like no other, and despite the global challenges, it has been a big year for us at Formus Labs.
Read StoryFormus CEO Ju Zhang on some of the challenges and opportunities facing us over the next 12 months and beyond.
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The Formus Labs team has recently debuted a tech demo of 'Formus Spine' at the New Zealand Orthopaedic Association (NZOA) conference held in Wellington this October. Formus Spine is currently in development as an AI-driven automated planning platform for spinal fusion surgery.
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The Formus Labs team recently returned from a successful trip exhibiting at the New Zealand Orthopaedic Association Annual Scientific Meeting, held at Te Papa in Wellington. Billed as “an extraordinary meeting in extraordinary times,” the NZOA ASM is likely to be the only orthopedic conference held globally for 2020.
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Formus Labs is pleased to announce that internationally regarded, Oxford-trained orthopaedic surgeon, Dr. George Grammatopoulos, has joined our growing clinical advisory board. Dr. Grammatopoulos will provide expert feedback on ongoing clinical evaluations and further development of Formus Labs’ AI-automated 3D pre-operative planning software.
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Formus Labs is proud to announce that we have recently been awarded ISO 13485 certification, a significant step toward achieving regulatory approval in international markets.
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A recently opened top-up round has further strengthened Formus Labs’ long-term capital outlook, despite the COVID-19 pandemic.
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