New Zealand-based medical technology manufacturer Formus Labs has received the US Food and Drug Administration (FDA) 510(k) approval for its Formus Hip software.

Formus Hip is an automated radiological image processing software designed to enable preoperative (pre-op) planning for hip replacement procedures.

It combines AI and computational biomechanics to calculate a patient’s implant fit and deliver digestible, actionable, and interactive 3D surgical plans.

The medical technology firm said that the current FDA approval allows the commercialisation of Formus Hip solution to surgeons and healthcare providers, supporting its plans to expand to the US.

Formus Labs founder and CEO Ju Zhang said: “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.

“FDA clearance serves as a significant validation of the accuracy and rigour 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 US now too.”

According to the company, pre-op planning allows surgeons to create a customised surgical plan before the procedure.

However, surgeons often face time constraints due to the large volume of cases and busy practices, which hampers proactive preoperatively planning for every case.

In addition, planning individual surgeries may take more time to complete, sometimes days or weeks, which is not desirable for surgeons with multiple procedures planned for a day.

Formus said that its advanced pre-op planning technology provides a surgeon with a personalised curated patient surgical plan before the patient enters the operating room.

The technology advances joint replacement planning by providing highly accurate outputs from scanning to planning, within one hour.

Formus board member Vignesh Kumar said: “The technology underlying the Formus solution helps drive potential improvement in orthopaedic patient outcomes.

“We’re thrilled the 510(k) approval now allows us to fully unlock our US commercialisation strategy to achieve positive outcomes for more patients.

“Formus is a great example of a digital health solution that balances the delicate ‘iron triangle’ of cost, access, and quality while addressing those core pain points in an elegant manner.”