List of Imaging Companies with Phase 1 Active Clinical Trial - 32

At Activ Surgical, our mission is for every surgical imaging system to deliver intelligent information that reduces surgical complication rates, ushering in a new standard of patient care and safety. Having completed the world’s first autonomous robotic surgery of soft tissue in 2018, the company is focused on enhanced, real-time visualization capabilities for surgeons that combine advanced augmented reality (AR), artificial intelligence (AI), and machine learning (ML) technology. Our vision is to transform the collective surgical experience by leveraging emerging technologies and data into insights that make world-class surgery accessible for all.

We are dedicated to transforming lives by improving the journey to a healthy, beautiful smile. Discover your straight path to a bright future at Align Technology. As a part of our smart, diverse and fast-moving global team, you'll make an impact on the market leader that's moving an industry forward. Want to find out what's next for us—and for you? Follow us on LinkedIn for business updates and check out our current opportunities at www.aligntech.com/careers. 25 years ago, we pioneered the market for clear aligners. Since then, we have continuously innovated with new products and technologies that revolutionize treatments for doctors and their patients. Today, doctors and labs in over 100 markets use the Invisalign system, iTero intraoral scanners and exocad software to improve smiles for patients – from simple tooth alignment to complex corrections, kids to adults, orthodontics to multi-disciplinary restorative treatment. Learn more about Align Technology and our products: www.aligntech.com www.invisalign.com www.itero.com www.exocad.com

Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems for the treatment of patients with peripheral artery disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the arms and legs. The company’s mission is to radically change the way vascular disease is treated through the introduction of products based on its lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avinger’s current lumivascular products include the Lightbox imaging console, the Ocelot family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris, the first-ever image- guided atherectomy device, designed to precisely remove arterial plaque in PAD patients.

Caranx Medical is a healthcare technology company based in Nice, France, founded by a team of experts including an entrepreneur, a clinician, and a researcher. The company focuses on enhancing access to less invasive medical care through innovative technologies. Its mission is to standardize complex surgical procedures, reduce risks associated with human error, and improve outcomes for patients and healthcare providers. The company specializes in developing intelligent robotic systems to improve surgical precision. One of its key products is the TAVIPILOT, a robotic solution designed for aortic valve procedures. Caranx Medical is also advancing the field with TAVIPILOT Soft, an AI software for real-time guidance during heart valve implantation, which is set for FDA submission in January 2025. The company has achieved significant milestones, including the world's first robotic-assisted heart valve implantation in an animal in April 2024. With a diverse team of over 20 professionals skilled in robotics, software management, and artificial intelligence, Caranx Medical is committed to driving innovation in interventional cardiology and improving patient care worldwide.

Clear Guide Medical is a leader in next-gen medical imaging fusion and navigation technology. Our vision-based approach has been introduced in a family of clinical guidance products, including the CLEAR GUIDE SCENERGY for instrument guidance and SCENERGY FUSION for ultrasound and CT/MRI image fusion. Our products make minimally-invasive interventions like biopsies, ablations, pain injections, and peripheral nerve blocks efficient and cost-effective. The company is a privately-held spinout of the Johns Hopkins Medical Institutions and The Johns Hopkins University based in Baltimore, Maryland.

CoapTech is bringing a series of breakthrough medical devices to worldwide markets, leveraging a patented, disruptive platform technology called the Point-of-care Ultrasound Magnet Aligned (PUMA) System. The PUMA Platform will disrupt multiple medical procedures, reducing health care costs, and improving efficiency, safety, quality, patient experience, and access to services around the globe. Invented by Dr. Steven Tropello, a Johns Hopkins-trained critical care physician, the PUMA System enables diagnostic, interventional and therapeutic procedures in hollow organs. The system combines magnetic attraction for device placement guidance, and ubiquitous, low-cost, point-of-care ultrasound for visualization in hollow cavities. Our lead device, the PUMA-G, selected because of its low risk, clear FDA pathway, and strong commercial viability, is for the insertion of Gastrostomy (feeding) tubes. PUMA-G enables a point-of-care (i.e. bedside, as opposed to operating room) procedure for inserting gastrostomy tubes which can be quickly and easily performed by non-surgical providers. By eliminating specialty suites and specialist consultants, PUMA-G will save hospitals money and improve efficiency and safety for this common procedure. PUMA-G has been validated in human anatomy, and has a streamlined regulatory pathway based on FDA presubmission feedback.

EchoNous creates transformative handheld point-of-care ultrasound solutions by infusing premium ultrasound performance with industry-leading AI educational tools providing more clinicians with increased information faster. Visit our website at https://www.echonous.com/ Explore a directory of our most popular content https://linktr.ee/echonous.kosmos

ENDRA Life Sciences Inc. ("ENDRA"​) (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS™) platform to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only with CT & MRI - at a fraction of the cost, and at the point-of-care. ENDRA's first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA's goal is to bring new capabilities to ultrasound - thereby broadening access to better healthcare. For more information, please visit www.endrainc.com. Non-Alcoholic Fatty Liver Disease (NAFLD) is a condition closely associated with obesity, diabetes, hepatitis-C and certain genetic predispositions in which fat accumulates in the liver. NAFLD affects over 1 billion people globally and is estimated to cost the U.S healthcare system over $100B annually. NAFLD is often asymptomatic and, If left untreated, NAFLD can progress to inflammation (NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the greatest root cause of liver transplants. The only tools currently available for diagnosing and monitoring NAFLD are impractical: expensive Magnetic Resonance Imaging (MRI) or an invasive surgical biopsy.

Femasys is a biomedical company focused on transforming women's healthcare worldwide by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas. With an initial focus in the area of reproductive health, its two lead product candidates offer solutions to improve patient care and health economics: FemBloc®, a first and only non-surgical product for permanent birth control and FemaSeed™, a first and only directed sperm delivery product for infertility treatment. Femasys' FemVue® product for fallopian tube assessment by ultrasound is currently marketed in the United States as its main commercial priority. Femasys has also developed a novel technology platform for tissue sampling intended to be marketed alongside our other women-specific medical products in the physician's office setting.

Ferronova is an innovative medical device company, which has brought together a patented magnetic probe from the University of South Australia and iron magnetic nanoparticle technology from Victoria University of Wellington, to produce an advanced diagnostic system to improve the detection of cancer metastases. Ferronova has research collaborations with UniSA Future Industries Institute, the University of Sydney, and the University of New South Wales. Founded in 2016, Ferronova is backed by Uniseed, Artesian Ventures, ASX-listed investment group Powerhouse Ventures, PAN Ventures, UniSA Ventures and Wellington UniVentures. The South Australian government and Australian government have provided grant funding to develop the technology.

From the beginning Sonosite has been dedicated to empowering clinicians to continue innovating the practice of medicine for the sake of providing better patient care. They continue to partner with clinicians to bring the benefits of ultrasound to the point-of-care.

Genetesis is a rapidly growing medical imaging company leveraging data science and biomagnetism in the fight against cardiovascular disease.

Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today's best-in-class technologies. Gentuity was founded on the principles of advancing patient care, improving outcomes, and expanding the utility of intravascular procedural guidance tools in the realm of cardiovascular disease. The Gentuity High-Frequency OCT Imaging System is the first commercially available OCT imaging system to deliver Total Vessel Imaging with the first 1.8F micro-imaging catheter. Gentuity and its' next-generation platform are paving the way for transformation in the intravascular imaging world. Designed to support the growing needs of the imaging industry, the platform incorporates AI and machine learning with the intention of creating "collaborative intelligence" to enhance ease of use and procedural success.

Invenio Imaging is a medical device start-up based in Santa Clara, CA dedicated to advancing the care of cancer patients by combining intraoperative histologic imaging with artificial intelligence. Our technology, the NIO® Laser Imaging System has been used in over 2500 cancer treatment procedures at major cancer centers both in the US and in Europe. In 2021 Invenio received a Medical Design Excellence Award, was selected to be a Rosenman Innovator and received CE Mark to commercialize in Europe.

KOELIS has assisted urologists and radiologists from around the world in their routine clinical practice since 2006, providing the latest technology for personalized prostate cancer planning and management, from biopsy to active surveillance and treatment. Focused on developing advanced, targeted and less invasive solutions, KOELIS is committed to creating and bringing to the market a new paradigm in prostate cancer care, where physicians can offer the most personalized answers to their patients, avoiding any under or overtreatment and preserving quality of life. Thanks to cutting-edge imaging tools like Trinity® cartographer, which combines multiple imaging modalities with full 3D ultrasound, any suspicious lesion is characterized in a detailed 3D prostate map, offering a comprehensive and multiparametric approach and enhancing diagnostic confidence. The team at KOELIS innovates every day in collaboration with world-renowned universities and hospitals to offer physicians new advancements in imaging and a greater field of view, a must-have in active surveillance and targeted treatment. Based in Grenoble and Princeton, KOELIS technology has been featured in more than 50 clinical publications and treats more than 300,000 patients worldwide, including patients in Europe, United States, Canada, Japan, Australia, South America and the Middle East.

Conquer Cancer through AI. Lunit is a public company that develops medical AI software for cancer screening and treatment. Lunit AI can empower you to enhance diagnostic performance. Our AI for chest x-ray and 2D & 3D mammography has been validated through 100+ publications in peer-reviewed journals such as JAMA Oncology, Lancet Digital Health and Radiology, and is now in use in 3,500+ sites globally. < Lunit AI Suite for Radiology > • Lunit INSIGHT CXR, AI Solution for Chest X-ray • Lunit INSIGHT MMG, AI Solution for Mammography • Lunit INSIGHT DBT, AI Solution for Digital Breast Tomosynthesis • Lunit CXR Triage, AI solution for Chest X-ray Triage *emergency department use, available in the US only *If you are interested in Lunit Oncology, please visit Lunit Oncology’s LinkedIn page.

As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care. Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

MolecuLight Inc. a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s suite of commercially released devices, including the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, provide point-of-care handheld imaging devices for the global wound care market for the real-time detection of wounds containing elevated bacterial burden > 10^4 CFU/g (when used with clinical signs and symptoms) and for digital wound measurement #moleculight

Noah Medical is a medical technology company based in San Carlos, California, founded in 2018. The company specializes in developing advanced medical robotics aimed at enhancing diagnostic procedures in pulmonology. Its flagship product, the Galaxy System, is a robotic platform that integrates real-time navigation, augmented fluoroscopy, and tomosynthesis to improve the accuracy of lesion localization, which is vital for early lung cancer diagnosis and treatment. With a team of over 150 engineers and industry experts, Noah Medical leverages extensive experience from leading healthcare companies. The company's mission focuses on saving lives through early diagnosis and treatment, particularly in robotic navigated bronchoscopy. Noah Medical has received recognition as a "Fierce 15" company of 2023 and has raised $150 million in funding to support its innovative approach. Its technology is designed to enhance procedural efficiency and diagnostic accuracy in healthcare facilities, particularly in pulmonology and oncology.

When a five-year-old boy was blinded after a regular eye exam failed to spot a retinal detachment, his father made it his life's work to help eye care professionals by revolutionising retinal imaging. Optos was founded by Douglas Anderson with the goal to make a patient-friendly device to capture a digital ultra-widefield image of the retina. Today, millions of patients around the world have benefited from optomap® retinal imaging. You will find optomap systems in many independent High Street optometrists, as well as eye clinics at Great Ormond Street Hospital in London and Harvard Medical Center in Massachusetts. Our core products produce high resolution optomap images of 82% or 200◦ of the retina, something no other imaging device is capable of in a single comfortable capture. The most recent innovation from Optos integrates ultra-widefield retinal imaging and image-guided Optical Coherence Tomography (OCT). This combined device facilitates the early detection, management and effective treatment of disorders and diseases evidenced in the retina such as retinal detachments and tears, glaucoma, diabetic retinopathy, and age-related macular degeneration. More than 1,000 published and ongoing clinical trials as well as thousands of case studies and testimonials show the long-term value of optomap imaging and OCT in diagnosis, treatment planning, and patient engagement. As a division of Nikon Co. Ltd, Japan since 2015, Optos is approaching its 30th anniversary and proud to be recognized as a leading provider of devices to eye care professionals to provide a more complete approach to patient care.

Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its noninvasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit www.polarean.com.

PROCEPT BioRobotics is a medical robotics company that specializes in minimally invasive robotic surgery technology.

Radialis is advancing precision medicine by providing the next generation of organ-targeted positron emission tomography (PET).

The company uses biology-guided radiotherapy to detect and respond to signals emitted from cancer cells, and use them to guide treatment.

SamanTree Medical proposes a breakthrough innovation for checking complete tumor removal during surgery: the Histolog® Scanner. This novel imaging modality is a direct support during cancer surgery to achieve the common goal of improving patient quality of life by decreasing rates of re-operation. The team is fully dedicated to bringing the Gold Standard in the operating room, enabling margin assessment, in real time, at the histological detail. SamanTree Medical SA was founded in December 2014 and is a spin-off of the EPFL (Ecole Polytechnique Fédérale de Lausanne). linktr.ee/SamanTree

Siemens Healthineersenables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare.COVID-19: CE mark for its molecular Fast Track Diagnostics (FTD)SARS-CoV-2 Assay.

Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins focused on Empowered Patient Care. The company has developed a portfolio of novel ultrasound solutions that empower patient care by delivering critical visual and quantitative data to improve outcomes and reduce costs. EchoMark is a bioresorbable and highly echogenic (visible under ultrasound) implant used to mark at-risk blood vessels such that the site can be easily assessed for future complications. EchoSure is a deep-learning enabled 3D automated ultrasound device designed to be used by healthcare providers without ultrasound training to assess blood flow and morphology of vessels marked by the implanted EchoMark device. For more information, please visit http://www.sonavex.com

Subtle, Inc., is a medical imaging software company. Our goal is to improve the quality, value, and accessibility of medical imaging by significantly reducing cost, imaging time, and radiation dose. We use the state-of-art proprietary deep learning AI algorithms to renovate the radiology workflow to deliver faster, safer and smarter solutions for imaging exams.

Terran Biosciences is a biotech platform company devoted to the development of therapeutics and technologies for patients with neurological and psychiatric diseases. Their portfolio includes a late-stage therapy for schizophrenia, late-stage selective serotonin 2A receptor antagonists, a drug design engine that has enabled first-in-class and best-in-class psychedelic therapies, and an AI-enabled imaging software platform.

Therapixel is a leading french software company specialized in artificial intelligence for medical imaging. Our aim is to develop a digital radiologist achieving the performance of best experts. Our AI is dedicated to breast cancer screening. That algorithm won the Digital Mammography DREAM Challenge, the largest Artificial Intelligence challenge ever organized. In its early years, Therapixel developed images visualization software for surgeons to make image access easier and faster from patient consultation to the operating room thanks to gesture control and intuitive user interfaces.

Trice Medical™ was founded to fundamentally improve orthopedic diagnostics for the patient, physician, and payer by providing instant, eyes-on, answers. Trice has pioneered fully integrated camera-enabled technologies that provide a clinical solution that is optimized for the physicians office. Our mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

ZOLL Medical is a medical devices company that specializes in healthcare technology for emergency response, with a focus on cardiac care and resuscitation.