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Formus Labs, Pioneering Developer of AI-Powered 3D Orthopedic Surgery Planning Technology, Receives FDA Clearance

Thursday, May 04, 2023

Formus Labs Receives FDA Clearance for Formus Hip, the First Automated Radiological Image Processing Software for Hip Replacement Pre-op Planning

Formus Labs, a New Zealand-founded company, has obtained 510(k) clearance from the FDA for Formus Hip, a groundbreaking automated radiological image processing software designed for pre-operative planning in hip replacements. This milestone achievement marks Formus' readiness to make its innovative solution widely accessible to surgeons and healthcare providers in the United States.

With the number of joint replacements projected to double by the end of the decade, pre-operative planning plays a crucial role in enabling surgeons to create customized surgical plans. However, time constraints often hinder comprehensive pre-operative planning, especially considering the heavy caseloads and busy schedules of surgeons. Planning individual surgeries can be extremely time-consuming, taking days or even weeks to complete, which is not sustainable or scalable for surgeons performing multiple procedures per day.

Formus addresses these challenges by combining artificial intelligence (AI) and computational biomechanics to calculate the ideal implant fit for each patient, delivering interactive and actionable 3D surgical plans. This innovative technology provides surgeons with personalized, curated surgical plans prior to the patient entering the operating room. The system's high accuracy and efficiency enable it to generate surgical plans within an hour, revolutionizing the pre-operative planning process.

Dr. Ju Zhang, founder and CEO of Formus Labs, expressed enthusiasm about the milestone, stating, "Today is a huge milestone in our journey to bring cutting-edge, pre-op surgery planning tools to surgeons, not only to make their work easier and more efficient, but also to improve patient outcomes. FDA clearance serves as significant validation of the accuracy and rigor of our AI models. Surgeons in Australia and New Zealand who have used the Formus platform praise the pre-op plans for facilitating the resolution of unforeseen challenges during surgery, thanks to a thorough understanding of each patient's physiology. This technology also has the potential to save costs, streamline logistics, and optimize inventory management. We are excited to offer these benefits to providers in the United States as well."

Vignesh Kumar, co-managing partner at GD1 and a board member of Formus, highlighted the potential impact of the technology on orthopedic patient outcomes, saying, "The underlying technology of the Formus solution has the potential to drive improvements in orthopedic patient outcomes. We are thrilled that the 510(k) approval now enables us to fully implement our commercialization strategy in the United States, ultimately benefiting more patients. Formus exemplifies a digital health solution that successfully balances cost, access, and quality while elegantly addressing core pain points."

Formus Labs' FDA clearance for Formus Hip opens up new possibilities for enhanced pre-operative planning in hip replacements, promising improved surgical outcomes, reduced costs, and increased efficiency for healthcare providers.

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