Formus Labs receives FDA clearance for AI-powered orthopedic planning software
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Key takeaways:
- Formus Labs received FDA clearance for its automated radiological image-processing software, Formus Hip.
- Formus Hip was developed to improve preoperative planning via AI and computational biomechanics.
Formus Labs announced FDA 510(k) clearance for its Formus Hip, an automated radiological image-processing software that will be used for hip replacement and preoperative planning, according to a press release.
According to the release, Formus Hip combines artificial intelligence and computational biomechanics to create 3D surgical plans to personalize patients’ surgical process.
“Today is a huge milestone in our journey to bring cutting-edge, [preoperative] surgery planning tools to surgeons, not only to make their work easier and more efficient, but also has the potential to improve the outcomes for their patients,” Ju Zhang, CEO and founder of Formus Labs, said in the release. “FDA clearance serves as significant validation of the accuracy and rigor of our AI models. The surgeons who have used the Formus platform in Australia and New Zealand tell us they like having [preoperative] plans that make facing any unforeseen challenges on the day of the surgery easier to overcome because of the thorough understanding of each patient's physiology. It also has huge potential to save costs, time spent on logistics and inventory. We’re excited to bring those same potential savings to providers in the U.S. now too.”
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