FDA approves hip surgery technology from Medacta
Medacta announced it has received FDA clearance for its MyHip Planner and MyHip Verifier, according to a press release.
The hip replacement tools have also received approval from Australia’s Therapeutic Goods Administration and from the Japanese Ministry of Health, Labour and Welfare.
“With our new MyHip Planner and MyHip Verifier, Medacta is enriching its integrated digital ecosystem, according to our holistic approach to personalized medicine,” Francesco Siccardi, CEO of Medacta, said in the release.
The MyHip Planner is a surgeon-operated CT-based software for creating preoperative 3D plans. The software involves 3D reconstruction of a patient’s anatomy, as well as real-time postoperative simulation to help surgeons make better implantation decisions. The planner is expected to detect risks like impingement, reduced range of motion and joint instability, according to the release.
The MyHip Verifier is a non-invasive surgical platform that uses intraoperative fluoroscopic images to assist surgeons verify implant positioning. The product offers real-time evaluations of factors such as leg length, offset and cup position. The company expects it will improve surgical outcomes in relation to complications like dislocation and joint laxity.