Joint replacement technology company Formus Labs has earned 510(k) clearance from the FDA for its image processing software for hip replacement preoperative planning.
The international company recently announced plans to expand into the U.S., now clearing a major hurdle that will allow Formus to start making its software available to surgeons and healthcare providers.
Pre-op planning software allows surgeons to create custom surgical plans, saving time in the operating room, according to a May 3 press release.
Formus combines AI with computational biomechanics to calculate a patient's implant fit and deliver custom surgical plans.