Surgical Navigation Systems in Texas

Perimeter Medical Imaging AI is a medical technology company specializing in intraoperative optical coherence tomography (OCT) imaging systems enhanced with artificial intelligence for cancer surgery guidance. The company's FDA-cleared Perimeter S-Series OCT and next-generation B-Series OCT with ImgAssist AI software provide real-time, cellular-level margin visualization during breast-conserving surgery and other oncologic procedures. These systems enable surgeons to identify residual tumor tissue and assess surgical margins with unprecedented clarity, reducing re-excision rates and repeat surgeries. Perimeter's technology leverages advanced optical imaging and machine learning algorithms to deliver actionable intraoperative insights, helping surgical teams close with confidence while improving patient outcomes and lowering healthcare costs. The company operates from Dallas, Texas with headquarters in Toronto, Canada.

Orthofix is a global medical device company specializing in orthopedic and spinal reconstruction solutions. The company manufactures a comprehensive portfolio of products and therapies addressing spinal conditions, limb reconstruction, and bone healing. Key product lines include spine fusion hardware and biologics (OsteoCove putty), bone growth stimulation therapies (AccelStim, CervicalStim, SpinalStim), limb reconstruction systems for congenital and acquired deformities, and the 7D FLASH surgical navigation platform—a machine-vision-enabled system offering radiation-free 3D image guidance for spine and cranial procedures. Orthofix's approach integrates mechanical, biological, and electromagnetic treatment modalities. The 7D FLASH system features streamlined registration (30 seconds vs. 30 minutes), sterile-field control, and superior surgical precision. The company serves orthopedic surgeons, spine surgeons, and orthopedic trauma specialists globally, with established clinical evidence and medical education programs supporting the complete patient pathway. Manufacturing and R&D capabilities are documented through product development initiatives and regulatory submissions. Orthofix maintains ISO and regulatory compliance appropriate to medical device classifications and operates manufacturing facilities supporting international distribution.

Fiagon GmbH is a manufacturer of electromagnetic navigation systems for ENT (otorhinolaryngology), sinus surgery, ear surgery, and cranio-maxillofacial (CMF) procedures. The company specializes in image-guided surgical navigation technology that enables precise, minimally invasive surgical planning and execution. Their product portfolio includes the Cube 4D Navigation System, which employs electromagnetic navigation to facilitate complex and routine otolaryngological procedures with high safety and efficiency. Fiagon also offers VirtuEye, a contactless photo registration system for patient positioning and registration completed in under one minute, designed for intuitive use across multiple surgical team members. The company manufactures flexible navigation instruments including PointerShells, FlexTubes, and FlexPointers that adapt to patient anatomy while enabling simultaneous functional capabilities such as suction and palpation. Their instruments support integration with standard surgical tools and burrs for comprehensive navigational guidance. Fiagon has received multiple innovation awards (Innovation of the Year 2016, Top Innovator 2015, Innovator of the Year 2014), indicating recognition within the surgical technology sector. The company serves hospitals and surgical centers globally with products designed to improve surgical accuracy and reduce operative time in complex head and neck procedures. Specific regulatory certifications and 510(k) status information were not visible in the provided content.

PolarisAR Inc. develops mixed-reality surgical guidance technology for orthopedic procedures. The company's flagship product, STELLAR Knee, is a mixed-reality surgical navigation system designed for Total Knee Arthroplasty (TKA) procedures. STELLAR Knee delivers real-time, targeted surgical guidance directly onto the surgical field, enabling surgeons to simultaneously view patient anatomy and critical data. The system provides robot-like precision without the complexity or cost of conventional robotic surgery platforms. Key differentiators include seamless operating room integration with no requirement for external monitors, cameras, or towers; intuitive hand gesture and voice command control within the mixed reality environment; and compatibility with any implant system, allowing surgeons to select preferred implants while maintaining procedural flexibility. STELLAR Knee is designed to democratize access to advanced surgical technology by minimizing infrastructure costs and supporting diverse surgical workflows. The system functions as a digital surgical assistant, enhancing surgeon proficiency, workflow efficiency, and situational awareness during knee arthroplasty. PolarisAR targets orthopedic surgeons and surgical centers seeking precision guidance technology that balances advanced capability with cost-effectiveness and operational simplicity.

Globus Medical, Inc. is a musculoskeletal medical device company specializing in spine surgery, orthopedic implants, and enabling surgical technologies. The company develops procedurally integrated portfolios for minimally invasive and open spine procedures, including TLIF (Transforaminal Lumbar Interbody Fusion), XLIF (Lateral Lumbar Interbody Fusion), and expandable interbody spacers. Key technology platforms include Excelsius Technology (an ecosystem of advanced OR technologies), Advanced Materials Science featuring PEEK and titanium implants, and proprietary magnetically adjustable systems for limb reconstruction (Precice). The company manufactures cervical disc replacements (Simplify Cervical Disc), power instruments (Verzera and DuraPro), and surgical navigation systems designed to improve safety and clinical outcomes. Globus Medical serves spine surgeons, orthopedic surgeons, and hospital systems globally through a comprehensive portfolio addressing sagittal alignment, fusion, fixation, and patient anatomy protection. The company emphasizes procedural integration, clinical education, and surgeon training through its Medical Education & Research Center (MERC), offering multimodal learning pathways and continuing surgical education. Manufacturing capabilities include advanced materials processing and enabling technology integration. The organization operates with regulatory compliance across major markets and demonstrates commitment to improving quality of life for patients with musculoskeletal disorders through innovation and surgeon partnership.

MedCAD is a Dallas-based medical technology company founded in 2007, specializing in patient-matched surgical devices and virtual surgical planning solutions. The company leverages advanced 3D imaging, CAD software, and precision manufacturing to design customized implants, surgical guides, and anatomical models for complex reconstructive and corrective procedures. Core offerings include the AccuPlan® Surgical Planning System for virtual surgical design, AccuPlate® 3D-printed titanium reconstruction plates, AccuShape® cranial implants in PEEK or titanium, AccuModel® anatomical models for surgical visualization, and AccuStride® foot and ankle surgical solutions. MedCAD serves cranial, maxillofacial, orthognathic, oral, plastic, and orthopedic surgery specialties. The company manufactures in-house in Texas with FDA clearance for its surgical products. MedCAD's approach combines engineer and design expertise—including trained sculptors and product designers—to create precision instruments and implants tuned to individual patient anatomy, enabling surgeons to plan procedures virtually, reduce operative time, and improve clinical outcomes.