Formus Labs today announced FDA clearance of its Formus Hip automated radiological image processing software for hip replacement pre-op planning.
The New Zealand–founded company described the clearance as the last hurdle it needed to overcome to start making Formus Hip widely available in the United States.
According to Formus Labs, its software saves time for orthopedic surgeons so that they can consistently preoperatively plan for every case. Formus’ software combines AI and computational biomechanics to provides highly accurate outputs from scan to plan in under an hour.
“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 has the potential to improve the outcomes for their patients,” Dr. Ju Zhang, founder and CEO of Formus Labs, said in a news 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 pre-op 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.”
The news comes more than a year after Formus Labs announced a $5 million money raise and a partnership with Zimmer Biomet to co-develop and commercialize Formus Hip in New Zealand and Australia.