Surgical Navigation Systems in California

Mendaera develops the Focalist™ handheld robotic system, a breakthrough medical device that combines robotics with real-time ultrasound imaging to enhance needle-based clinical procedures. The system is designed to improve clinician precision and confidence during interventional ultrasound-guided procedures by providing automated targeting and trajectory visualization. The Focalist system integrates two core technologies: a handheld robotic component that stabilizes and guides needle placement, and real-time ultrasound imaging with target trajectory visualization. This combination addresses the complexity and skill requirements of traditional ultrasound-guided needle procedures, enabling clinicians to perform interventions with greater accuracy. Mendaera received FDA clearance for the Focalist system and is preparing for broad commercial launch in 2026. The company targets healthcare providers performing needle-based interventions across multiple clinical specialties. The device represents a significant advancement in image-guided surgery and interventional medicine, addressing a critical gap in procedural precision and operator-dependent variability.

OrthAlign, Inc manufactures surgical navigation and alignment technology for orthopedic joint replacement procedures. The company's primary product platform is Lantern®, a handheld navigation system designed to improve precision and efficiency in total hip arthroplasty (THA), total knee arthroplasty (TKA), revision knee procedures, and partial knee arthroplasty (PKA). Lantern Hip and Lantern Knee are modular product lines that enable surgeons to perform joint replacements with enhanced accuracy in various surgical settings, including ambulatory surgery centers (ASCs), hospital operating rooms, and outpatient facilities. The technology is characterized as simple and efficient, designed to work with any surgeon and any OR setup without requiring specialized infrastructure. OrthAlign positions its offerings for the growing outpatient joint replacement market, emphasizing accessibility and ease of adoption across diverse surgical environments. The company maintains a surgeon finder tool to help patients locate practitioners using OrthAlign technology. While specific regulatory certifications are not detailed in the available content, orthopedic surgical navigation systems typically require FDA 510(k) clearance for US distribution. The company's focus on ASC compatibility and surgeon accessibility suggests a market strategy targeting both high-volume academic centers and emerging outpatient surgical venues.

SURGLASSES Inc. (Taiwan Main Orthopaedic Biotechnology Co., Ltd.) is a medical technology manufacturer specializing in augmented reality (AR) surgical guidance systems for orthopedic and neurosurgery applications. The company develops computer-assisted surgical navigation platforms designed to reduce X-ray radiation exposure, improve surgical precision, and enable minimally invasive procedures. Core product lines include the Caduceus S AR Navigation System (FDA 510(k) cleared in December 2022), a spine 3D computer surgery navigation system, and surgical planning software. The company also manufactures medical education platforms, including the Asclepius Virtual Dissection Table (available in multiple sizes for institutional use) and the Asclepius AI Table, described as the world's first AI-powered anatomy table featuring integrated modules for anatomy, radiology, histopathology atlas, and CT rendering. The Asclepius platform supports online examination and anatomy app functionality for medical schools and training institutions. SURGLASSES holds FDA 510(k) clearance and serves hospitals, physicians, and patients across North America and Asia-Pacific markets. The company reports completion of the first AR surgery procedure in the United States (April 2023). Operations include manufacturing and distribution facilities in Taiwan and the United States, with focus on reducing surgical time, improving outcomes, and lowering procedural costs through advanced visualization and navigation technologies.

Eigen Health is a California-founded medical technology company (established 1975) specializing in advanced MRI-ultrasound fusion systems and minimally invasive focal therapies for prostate cancer diagnosis and treatment. The company operates in 36+ countries, serving academic institutions, hospitals, and clinical practices globally. The Artemis platform is their flagship 3D semi-robotic prostate biopsy system featuring real-time organ tracking and prospective needle navigation with switchable transrectal and transperineal modules. It performs rigid and elastic registration of multimodal imaging (MRI, PET-CT, PSMA PET-MRI) to real-time ultrasound. The TPO (Transperineal Operative) module is purpose-built for transperineal approaches with integrated ultrasound capabilities. ProFuse CAD is their advanced radiology software for computer-assisted detection, real-time mpMRI analysis, and MRI data preparation for fusion guidance. The Cryo product combines MRI/ultrasound fusion-guided biopsy with cryoablation for minimally invasive, often outpatient prostate cancer treatment. The company reports supporting clinical outcomes for over 3,000,000 patients worldwide and maintains multiple patents in fusion imaging and needle guidance technology. ISO 13485 certified, indicating compliance with medical device quality management standards. The company emphasizes long-term partnerships with distributors and clinical institutions for seamless technology integration into practice and research.

EchoPixel develops a software platform that converts standard medical imaging data into interactive 4D holographic visualizations for surgical planning and intraoperative guidance. The platform creates patient-specific digital twins that physicians experience as real physical objects without requiring headgear or glasses, enabling precise visualization of complex anatomical relationships during minimally invasive procedures. The technology is particularly applied in structural heart and congenital heart interventions, providing real-time situational awareness of catheters and implantable devices relative to patient anatomy. The company's core offering addresses limitations of traditional 2D and 2.5D imaging by reducing procedure complications and expanding access to minimally invasive therapies. EchoPixel's solution is FDA 510(k) cleared and deployed in leading hospital systems. The platform serves as a turnkey surgical guidance system that integrates with existing hospital imaging workflows, designed for cardiology, interventional radiology, and cardiac surgical teams. Manufacturing and software development capabilities are based in San Jose, California.

View Point Medical is a medical device company developing the OneMark Detection Imaging System, a surgeon-centric localization and imaging platform designed to detect and visualize visually enhanced markers placed during biopsy for precise tissue resection. The system enables intraoperative detection of marked lesions, particularly in breast cancer surgery, eliminating the need for preoperative localization device placement and reducing re-excision rates. The OneMark system represents a workflow innovation that decouples radiology and surgical scheduling while improving clinical and economic outcomes through simplified, minimally invasive localization. The company is focused initially on breast cancer indications with development underway for additional oncologic applications. Founded by experienced medical device entrepreneurs and clinical innovators, the company has assembled a leadership team with expertise in minimally invasive surgery, regulatory affairs, and medical device commercialization. The regulatory team brings over 40 years of FDA navigation experience.

Carlsmed is a publicly traded medical technology company specializing in AI-enabled personalized spine surgery solutions. The company's flagship aprevo® platform integrates artificial intelligence and 3D printing technology to design custom titanium spinal implants and deliver detailed, patient-specific surgical plans. The platform includes 3D surgical planning and visualization (myaprevo®), personalized procedural protocols, and biomechanically optimized implants designed to promote fusion. FDA-cleared for lumbar and cervical spinal fusion procedures, Carlsmed has completed over 50 cases. The company targets the substantial U.S. market opportunity of approximately 445,000 annual lumbar spine fusion procedures. With strong clinical evidence foundation and ISO 13485 certification, Carlsmed is expanding internationally following its July 2025 IPO.

Unik Orthopedics develops personalized medical devices and cloud-based surgical planning software for total knee and hip replacement procedures. The company provides an open-platform solution combining advanced imaging analysis, customized 3D surgical planning, personalized single-use surgical instruments, and robotic-assisted technologies that work with any implant brand. Using MRI or CT imaging, the company creates precise 3D anatomical models of each patient, enabling surgeons to develop individualized surgical plans optimized for implant size, alignment, and placement. Custom instruments are manufactured in their California facility and delivered within two weeks of imaging. The technology reduces surgical steps, requires fewer instruments, and improves procedural efficiency and consistency compared to conventional instrumentation. Unik Orthopedics partners with healthcare facilities, orthopedic surgeons, and implant manufacturers to enhance patient outcomes and surgical precision. The company positions its personalized approach as reducing error margins and improving patient satisfaction in joint replacement surgery.

Ceevra is a medical software company that develops FDA-cleared machine learning and computer vision algorithms to generate detailed, interactive 3D digital models from CT and MRI imaging studies. The platform automatically processes imaging data without requiring manual input from hospital personnel and delivers 3D surgical visualization accessible on mobile devices, tablets, laptops, and integrated surgical robotic displays. Ceevra's 3D models are clinically validated to improve surgical planning and patient outcomes across multiple surgical specialties including thoracic, urologic, gynecologic, and general/hepatopancreaticobiliary (HPB) surgery. The solution supports open, laparoscopic, and robotic-assisted surgical approaches. Clinical evidence published in JAMA Network Open demonstrates significant improvements in surgical outcomes, including enhanced cancer control, functional preservation, and reduced adjuvant therapy rates in robotic urologic procedures. Ceevra serves major U.S. healthcare systems including UCLA Health, Mayo Clinic affiliates, Memorial Sloan Kettering, Baptist Health South Florida, and Tulane University School of Medicine. The company operates on a subscription model with implementation designed for rapid deployment across hospital networks.

Cision Vision is a medical technology company specializing in shortwave infrared (SWIR) imaging systems for pathology and surgical applications. Founded in 2020 as an MIT spinoff, the company's flagship InVision device provides label-free, real-time imaging that enhances lymph node identification and tissue grossing in laboratory and intraoperative settings. The technology leverages SWIR wavelengths (1000–2000 nm) to penetrate biological tissues deeply and provide natural contrast based on water and lipid content, eliminating the need for contrast agents or radiation. InVision has been recognized as one of Time Magazine's Best Inventions of 2023 and is deployed across multiple U.S. hospitals. The company's surgical application focuses on AI-powered critical structure identification during intraoperative guidance. Cision Vision has received significant government funding, including a prestigious ARPA-H award of up to $22.3 million as part of the Biden Cancer Moonshot initiative. The company collaborates with leading institutions including Johns Hopkins Medicine and Stanford Medicine, and operates the Visionary Program to support early-access initiatives for pathology innovators. Clinical validation includes a multicenter study published in the Journal of Clinical Pathology.

Radlink, Inc. is a medical device software company specializing in intraoperative imaging navigation and surgical guidance systems for orthopedic surgery, with primary focus on hip arthroplasty (total hip replacement). The company develops AI-powered software platforms that integrate with standard fluoroscopy (C-arm and mobile X-ray) systems to provide real-time, patient-specific surgical guidance without requiring specialized hardware or invasive tracking. Core products include Radlink One Touch (redesigned surgeon's checklist interface), Radlink Hip (anterior and posterior approach THA software), Radlink3D (3D intraoperative assessment of acetabular cup and femur positioning with spinopelvic mobility analysis), Panoramic Fluoro (panoramic fluoroscopic imaging), and OrthoPlan 2.0 (preoperative planning). The platform operates as an open system compatible with any implant brand and any C-arm or mobile X-ray device on the market. Software enhancements include spinopelvic assessment for functional component positioning and leg length discrepancy prediction. Radlink also offers DR Pro (digital radiology software) and PACS/EMR/Citrix integration capabilities. The company markets to surgeons, hospitals, and health systems seeking to improve OR efficiency, reduce costs, and enhance clinical accuracy. Headquarters: El Segundo, California. The technology is clinically validated with peer-reviewed publications in orthopedic journals and is actively promoted through industry conferences including AAHKS (American Association of Hip and Knee Surgeons).

Illuminant Surgical develops real-time surgical navigation systems using artificial intelligence, computer vision, and dynamic projection mapping to enhance image-guided procedures. The company's flagship product, Skylight™, is a non-invasive anatomical projection system designed for spine surgery and interventional access procedures. Skylight projects imaging directly onto the patient's anatomy, eliminating the cognitive burden of traditional navigation systems that require surgeons to mentally translate 2D scans into 3D spatial awareness while constantly shifting attention between screens and the surgical field. The system employs SkinMatch™ patient registration technology to streamline workflow integration into any procedure room with minimal training (one day) and setup time (minutes rather than 30+ minutes). Illuminant Surgical addresses a critical gap in surgical technology by making advanced navigation accessible beyond major medical centers—scaling the solution to ambulatory surgical centers, private specialty clinics, and pain management facilities. The company's technology reduces operational friction, decreases OR costs, and expands treatment capacity. As of the website content, Skylight has not received FDA clearance and is not available for commercial use. The company is led by co-founders listed in Forbes 30 Under 30 Healthcare and is advised by prominent clinical and engineering leaders from USC Spine Center, Stanford Biodesign, and Stanford Medical Mixed Reality Lab, as well as business advisors including the founder of Masimo and former Stryker executive.

Navigate Surgical Technologies develops the Inliant System, a dynamic surgical navigation platform for freehand dental implant procedures. The system uses real-time motion tracking of the clinician's handpiece and patient position, overlaying precise drill angulation and trajectory on CBCT scans displayed in real-time during surgery. The platform comprises three core components: an attachment-free dental handpiece (requiring no pre-surgical calibration), a patient tracker set affixed to a chairside-fabricated stent for maintaining registration with the CBCT scan, and an optimized cart with full-length arm and adjustable monitor designed for any operatory configuration. The system enables same-day implant planning and surgery, eliminates or reduces intraoperative radiographs, and allows adaptive surgical planning in real-time. Primary clinical applications include single and multiple implant placement in aesthetically challenging zones, areas with questionable bone volume, limited vertical space, diverging roots, or tight interdental spacing. The Inliant System has received FDA 510(k) clearance. Navigate targets oral and maxillofacial surgeons, periodontists, and general dentists performing implant procedures.