FDA Authorizes First Surgical App for Apple Vision Pro

One field of view

SportSuite Vision lets a surgeon place the live arthroscopy camera feed, CT imaging, HipCheck measurements, and a HipMap surgical plan in virtual panels around the operating field. Apple Vision Pro’s camera view keeps the room, patient, and instruments visible behind those panels.

Mather said he could move the information to fit his workflow and reach it from within the sterile field.

Using spatial computing enabled me to customize the placement of key clinical information to fit my workflow and access it within the sterile field. This helped create a more comfortable, streamlined OR setup while keeping the information I needed in view.

Dr. Chad Mather III, Duke Health orthopedic surgeon and Stryker consultant

What the FDA authorized

De Novo is the FDA pathway for a new kind of low- or moderate-risk medical device without a legally marketed device to use as a direct comparison. The July 17 decision created a Class II category for this type of augmented-reality surgical display.

The authorization is narrow. SportSuite Vision is a prescription device for displaying arthroscopy video, medical imaging, HipCheck, and HipMap information during procedures for femoroacetabular impingement and labral repair. Stryker notes that CT scan data is for information rather than diagnosis.

The FDA requires a traditional monitor to remain available as a backup, and Stryker says other operating room staff use conventional monitors while the surgeon wears Apple Vision Pro.

What comes next

Stryker has opened a waitlist for surgical teams interested in SportSuite Vision, though pricing and a broader rollout date have not been announced. The first Duke case points to the system’s appeal: bringing the information a surgeon needs into one customizable field of view while preserving sight of the operating room.