# SmartAlpha — Full Content > SmartAlpha (smartalpha.ai) is a venture-capital-funded AI healthcare startup building real-time artificial intelligence for ultrasound imaging. Its FDA-cleared real-time AI guidance products — Nerveblox™ for ultrasound-guided regional anesthesia and MSK Go for musculoskeletal ultrasound — are available on select ultrasound systems from global imaging vendors including GE HealthCare and Siemens Healthineers. Running on more than 1,000 systems across 35 countries, SmartAlpha's user base is among the fastest-growing in healthcare AI. This file is the llms.txt companion with the site's full content. Summary: https://smartalpha.ai/llms.txt ## Key facts - Company: SmartAlpha — an AI healthcare startup focused on ultrasound AI and AI-guided ultrasound scanning - Mission: removing the skill barrier to ultrasound for a new generation of human users and robotic healthcare workers - Products: - Nerveblox™ — FDA 510(k) cleared and CE marked; real-time identification of anatomical structures for ultrasound-guided regional anesthesia across 12 supported procedures - MSK Go — FDA 510(k) cleared and CE marked; real-time anatomical highlighting for musculoskeletal ultrasound across 5 joints and 120 anatomical structures - Technology: proprietary, edge-ready AI supporting 50+ scan procedures and 200+ anatomical structures with real-time image-quality assessment, able to run on any hardware platform - Partners: GE HealthCare, Siemens Healthineers - Investors: Diffusion Capital Partners, TT Ventures, Koç GSYF, TIBAS, Eksim Ventures, GrowthCircuit, and day-one angel investors - Traction: running on more than 1,000 ultrasound systems across 35 countries - Contact: contact@smartalpha.ai ## Frequently asked questions (https://smartalpha.ai/solution/) ### What is SmartAlpha's main focus? Today, SmartAlpha focuses on the hardest part of the ultrasound workflow: obtaining the correct image. Image acquisition is the most time-consuming step of an examination, and the step behind most of the waiting times and costs clinics face. By combining anatomy awareness with real-time scan guidance, our technology helps healthcare professionals capture the right image easily and consistently. ### Where does the data behind SmartAlpha's AI come from? Our clinical and engineering teams design the data requirements for each product together, and the data is then collected prospectively to meet them, so quality is built in from the start. Datasets are diversified across the parameters that matter most for generalization, such as race, health conditions and pathologies. This end-to-end proprietary data workflow is how we build AI that is robust and reliable in real-world conditions and use cases. ### How do you ensure quality and safety? Our products are developed under internationally recognized medical device quality and regulatory standards, with rigorous engineering, testing and risk management throughout. They are validated with clinics and clinicians through clinical studies and real-world testing. Our initial products are FDA-cleared in the United States and CE-marked in Europe. ### How can I use SmartAlpha AI products in my practice? SmartAlpha partners with leading ultrasound manufacturers to bring its AI to clinics around the world. You can get it as part of a new ultrasound system, and where possible, your existing system can be updated to include it. [Contact us](https://smartalpha.ai/contact/) to find out which options are available for your practice. ### How does SmartAlpha's ultrasound AI technology enable robotic ultrasound users? Robotic scanning requires more than a mechanical arm: the system must understand what it is imaging. It has to recognize anatomical structures in real time, judge whether the image is good enough and complete, and know how to move the probe toward the right view. These are the same capabilities that assist clinicians today. SmartAlpha's AI is built to run in real time on any hardware platform, so it can serve as the intelligence layer for robotic ultrasound. ## Ultrasound and artificial intelligence, explained (https://smartalpha.ai/ultrasound-ai/) Ultrasound is the most accessible medical imaging modality. It is portable, affordable and free of ionizing radiation. It is also the most dependent on the person holding the probe: the system shows grayscale images, and knowing which anatomy is on the screen has always been the user's job. Artificial intelligence gives the system its own understanding of that anatomy. Here is what it does, where it helps and how it is regulated. ### What it does SmartAlpha delivers software that understands ultrasound images as they are acquired. Models trained on large sets of expert-annotated scans recognize anatomical structures such as nerves, vessels, muscles, tendons and bones, and label them on the live image. On top of that, it can help the user position the probe, judge whether the image is good enough, and confirm when the right view has been captured. Later steps such as measurements and reporting can be supported as well. All of this happens live. The probe moves and the image changes many times per second, so the software has to keep up with the user's hand. That is why it runs in real time, on the ultrasound system itself. ### Why it matters Reading sonoanatomy reliably takes years of training, and there are not enough experienced sonographers and specialists to meet demand. Patients wait for exams, clinicians work through full schedules, and results vary from one user to the next. Part of the reason is how an exam works today. Every scan is a close collaboration between an expert and a machine that does not understand what it shows. The expert finds the right view, recognizes the anatomy, takes the measurements and documents the result, all by hand. Much of that time goes into routine steps rather than clinical judgment. A machine with more intelligence changes that balance. When the system itself recognizes the anatomy, guides the probe to the right view and supports routine measurements, it simplifies what the expert must do at every step. Their attention can then go to what only an expert can do: interpreting what they see and deciding what it means for the patient. Each exam takes less effort, more patients can be seen, and waiting times come down. Routine scans can happen earlier, by the clinician already with the patient, and expert time is kept for complex cases. This is the real answer to the shortage: enable beginners and empower experts. Ultrasound is moving to the bedside, and anesthesiologists, emergency physicians, primary care doctors and nurses scan more often, usually without a radiologist or sonographer in the room. With expert knowledge built into the device, newer users can perform exams with confidence, while experienced sonographers and specialists spend less time on routine steps and can see more patients. ### Where it helps - Regional anesthesia, where anesthesiology AI highlights nerves, arteries and other landmarks to help anesthesiologists perform ultrasound-guided nerve blocks. - Musculoskeletal ultrasound of the shoulder, elbow, wrist and hand, knee, and ankle and foot, in sports medicine, orthopedics and rehabilitation. - General imaging, including abdominal ultrasound of the liver, gallbladder, kidneys and other organs, where liver AI can simplify quantification and measurements, such as fatty liver grading, to simplify the workflow. - Point-of-care settings such as emergency departments, primary care clinics and nursing homes, where clinicians scan occasionally. - Training, where annotated images help clinicians learn sonoanatomy faster. - Robotic ultrasound, since a robot also needs to know what anatomy is in view and whether it has the image the exam requires. ### How it is regulated AI that supports clinical work with ultrasound is regulated as a medical device. In the United States, most products reach the market through FDA 510(k) clearance. In the European Union, they need CE marking under the Medical Device Regulation and are registered in the EUDAMED database. ### Our work SmartAlpha builds the intelligence layer for ultrasound imaging. Our aim is to simplify what the expert must do during every exam, with real-time AI that recognizes anatomy and guides each step at the point of care, whether the user is a person or a robot. It is delivered as part of ultrasound systems from imaging vendors. Our initial offerings are already cleared for clinical use as medical devices in many countries. Our use-case portfolio is continuously expanding, with new developments in point-of-care and general imaging use cases such as AI for [regional anesthesia](/nerveblox/), [orthopedics](/orthopedics/), [sports medicine](/sports-medicine/) and abdominal ultrasound, including liver exams and measurements. You can read more about why we do this in [Putting Expert Knowledge Inside the Ultrasound](/why-we-started-smartalpha/), or [contact us](/contact/) about availability in your region. ## Nerveblox™ — 12 supported ultrasound-guided regional anesthesia procedures (https://smartalpha.ai/nerveblox/) ### Transversus Abdominis Plane (TAP) Transversus abdominis plane (TAP) block is a regional technique for analgesia of the anterolateral abdominal wall. TAP block anatomy landmarks are as follows: - Transverse Abdominis Muscle - Internal Oblique Muscle - External Oblique Muscle - Peritoneal Cavity ### Rectus Sheath The rectus sheath nerve block is a useful technique for umbilical surgery, particularly in pediatric patients. Rectus block anatomy landmarks are as follows: - Rectus Abdominis Muscle - Peritoneal Cavity - Rectus Sheath (Anterior Aspect) - Rectus Sheath (Posterior Aspect) ### Femoral The ultrasound (US)-the guided technique femoral nerve block is used for the femur, patella, quadriceps tendon, and knee surgery, and analgesia for hip fracture. Femoral block anatomy landmarks are as follows: - Femoral Vein - Femoral Nerve - Femoral Artery - Iliopsoas Muscle ### Adductor Canal An Adductor Canal nerve block is useful as a sciatic nerve block for foot and ankle procedures. Adductor block anatomy landmarks are as follows: - Femoral Artery - Sartorius Muscle - Vastus Medialis Muscle - Saphenous Nerve ### Popliteal Sciatic The popliteal fossa nerve block is a very clinically valuable technique that results in anesthesia of the calf, tibia, fibula, ankle, and foot. Popliteal block anatomy landmarks are as follows: - Common Peroneal Nerve - Tibial Nerve - Popliteal Artery - Popliteal Vein ### Erector Spinae Plane (ESP) Erector spinae plane (ESP) block is an interfascial plane block where a local anaesthetic is injected in a plane preferably below the erector spinae muscle. ESP block anatomy landmarks are as follows: - Trapezius Muscle - Erector Spinae Muscle - Transverse Process - Pleura ### Interscalene Brachial Plexus The interscalene approach to brachial plexus block results in reliable anesthesia of the shoulder and upper arm. Interscalene block anatomy landmarks are as follows: - Brachial Plexus - Anterior Scalene Muscle - Middle Scalene Muscle - Sternocleidomastoid Muscle ### Supraclavicular Brachial Plexus The supraclavicular approach to the brachial plexus block results in anesthesia of the upper limb including often the shoulder because all trunks and divisions can be anesthetized from this location. Supraclavicular block anatomy landmarks are as follows: - First Rib - Pleura - Subclavian Artery - Brachial Plexus ### Infraclavicular Brachial Plexus The infraclavicular block provides a block of the arm below the shoulder. Infraclavicular block anatomy landmarks are as follows: - Pectoralis Major Muscle - Pectoralis Minor Muscle - Axillary Artery - Axillary Vein ### Cervical Plexus The cervical plexus nerve block results in anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin, overlying and immediately inferior to the clavicle on the chest wall. Superficial block anatomy landmarks are as follows: - Carotid Artery - Sternocleidomastoid Muscle - Cervical Plexus - Jugular Vein ### Axillary Brachial Plexus The axillary brachial plexus block (including the musculocutaneous nerve) results in anesthesia of the upper limb from the mid-arm down to and including the hand. Axillary block anatomy landmarks are as follows: - Axillary Artery - Musculocutaneous Nerve - Conjoint Tendon - Ulnar Nerve - Median Nerve - Radial Nerve ### PECS I & II The pectoral nerve (Pecs) block I and II are a novel technique to block the pectoral nerves. These blocks can be used to provide analgesia for a variety of anterior thoracic wall surgeries, most commonly breast surgery. Pecs I & II block anatomy landmarks are as follows: - Pectoralis Major Muscle - Pectoralis Minor Muscle - Pleura - Rib ## MSK Go — supported joints and views (https://smartalpha.ai/msk-go/) - Shoulder: Biceps Tendon, Subscapularis Tendon, Supraspinatus Tendon, Rotator Interval, Acromioclavicular Joint, Glenohumeral Joint - Elbow: Common Extensor Tendon, Common Flexor Tendon, Humeroradial Joint, Humeroulnar Joint, Olecranon Fossa, Ulnar Nerve - Wrist & Hand: Carpal Tunnel, Radiocarpal Joint, Extensor Compartments, Flexor Pollicis Longus Tendon, Metacarpal Joint - Knee: Patellar Tendon, Suprapatellar Region, Femoral Trochlea Cartilage, Medial Collateral Ligament, Lateral Collateral Ligament, Pes Anserine Tendons, Distal Iliotibial Band - Ankle & Foot: Achilles Tendon, Plantar Fascia, Tibiotalar Joint, Anterior Talofibular Ligament, Calcaneofibular Ligament, Extensor Tendons, Flexor Tendons, Peroneal Tendons, Metatarsal Heads ## SonoFive — the daily sonoanatomy check (https://smartalpha.ai/sonofive/) SonoFive is a free daily sonoanatomy exercise by SmartAlpha, the developers of Nerveblox. Each day brings five real regional anesthesia ultrasound cases, read against the clock: name the region, find the structure, and check yourself against annotations made by human experts. It takes about two minutes a day and is intended for anesthesiologists, sonographers, and clinicians who use ultrasound. For educational use only; not for diagnosis or treatment decisions. ## News & announcements - [SonoFive is Live: Your Daily Sonoanatomy Check](https://smartalpha.ai/sonofive/) — Five real regional anesthesia cases a day, and the clock is running, just like at the bedside. Free and for educational use, built with the ultrasound experts SmartAlpha collaborates with every day... - [SmartAlpha Receives Second FDA Clearance Within a Year: MSK Go™, the Musculoskeletal Ultrasound AI](https://smartalpha.ai/smartalpha-receives-second-fda-clearance-within-a-year-for-msk-go-its-musculoskeletal-ultrasound-ai/) — MSK Go™, an AI software solution by SmartAlpha designed to assist clinicians in interpreting musculoskeletal ultrasound images in real time during the scan, has received U.S. FDA 510(k) clearance... - [Decentralized medical imaging is gaining pace with AI!](https://www.linkedin.com/posts/smartalpha_decentralized-medical-imaging-is-gaining-activity-6928007379963777024-9Nsu?utm_source=linkedin_share&utm_medium=member_desktop_web) — Soon, mobile healthcare specialists equipped with a handheld ultrasound device and SmartAlpha's technology... - [SmartAlpha Collaborates with GE HealthCare for Regional Anesthesia AI](https://www.prnewswire.com/news-releases/smartalpha-collaborates-with-ge-healthcare-for-regional-anesthesia-ai-302586652.html) — SAN ANTONIO Oct. 16, 2025/PRNewswire/ -- SmartAlpha announced its collaboration with GE HealthCare to commercialize Nerveblox™... - [Introducing SmartAlpha Co-Pilot](https://smartalpha.ai/introducing-smartalpha-co-pilot-revolutionizing-ultrasound-exams-with-ai-technology/) — SmartAlpha Co-Pilot is set to transform the way medical professionals conduct and interpret ultrasound exams... - [Nerveblox™ Granted FDA Clearance](https://smartalpha.ai/nerveblox-the-ultrasound-ai-for-regional-anesthesia-granted-fda-clearance/) — Ankara, August 18th, 2025 - Nerveblox™, an AI software solution by SmartAlpha, designed to assist physicians in... - [SmartAlpha Partners with Siemens Healthineers](https://smartalpha.ai/smartalpha-partners-with-siemens-healthineers-to-advance-ai-powered-workflow-efficiencies-in-ultrasound/) — Vienna, March 1st - SmartAlpha has announced a partnership with Siemens Healthineers with a signing ceremony at the ECR... - [SmartAlpha Welcomes Dr. Keerthi Vishnudas](https://www.prnewswire.com/news-releases/smartalpha-welcomes-dr-keerthi-vishnudas-as-company-accelerates-us-expansion-302536779.html) — ANKARA, Turkey, Aug. 22, 2025 /PRNewswire/ -- SmartAlpha, the ultrasound AI company delivering real-time AI solutions to expand the use of ultrasound... - [The Dawn of Large Language Models (LLMs) in Ultrasound](https://aiumthescan.blog/2024/11/12/the-dawn-of-large-language-models-llms-in-ultrasound//) — With the advent of large language models (LLMs), such as the well-known ChatGPT.... - [SmartAlpha precision is now mobile!](https://www.linkedin.com/posts/smartalpha_smartalphaprecision-digitalhealth-ultrasound-activity-7115713108202991616-J6XJ?utm_source=share&utm_medium=member_desktop) — Alongside the re-certification of Nerveblox® under the new EU Medical Device Regulation (MDR) - [Our first AI solutions are being adopted very fast!](https://www.linkedin.com/posts/smartalpha_ultrasound-aiinhealthcare-activity-6996126034370662400-Gig4?utm_source=share&utm_medium=member_desktop) — It was not easy to achieve this but we've accomplished great things in a short time... - [Excited to see our groundbreaking ultrasound guidance technology!](https://www.linkedin.com/posts/smartalpha_pajunkeducation-pajunk-reliablepartner-activity-6945045247043203072-Wnuu?utm_source=linkedin_share&utm_medium=member_desktop_web) — Excited to see our groundbreaking ultrasound guidance technology meet with healthcare professionals and... - [We are the winner of Medx@Düsseldorf startup competition 2021!](https://smartalpha.ai/we-are-the-winner-of-medxdusseldorf-startup-competition-2021/) — In a significant leap for artificial intelligence in healthcare, SmartAlpha, an innovative AI start-up specializing in ultrasound imaging, has emerged as the winner... - [Turkish AI solution offers instant diagnoses with ultrasound](https://www.dailysabah.com/business/tech/turkish-ai-solution-offers-instant-diagnoses-with-ultrasound) — SmartAlpha, which enables the results of ultrasonography devices to be rapidly evaluated with medical AI, is designed to be used to decide immediately... - [Announcement : Two new clinical trials](https://smartalpha.ai/announcement-two-new-clinical-trials/) — Nerveblox is an AI-driven decision support solution to encourage anesthesiologists practice peripheral nerve blocks (PNB)... - [AI for Regional Anesthesia Receives CE Marking Approval](https://smartalpha.ai/ai-for-regional-anesthesia-receives-ce-marking-approval/) — SmartAlpha announces that Nerveblox, the artificial intelligence driven image... - [Ultrasound & Peripheral Nerve Blocks](https://smartalpha.ai/ultrasound-peripheral-nerve-blocks/) — Everyday, more and more anesthesiologists are choosing ultrasound imaging for administering regional... - [Artificial Intelligence In Ultrasound Imaging](https://smartalpha.ai/artificial-intelligence-in-ultrasound-imaging/) — In the dynamic world of medical technology, artificial intelligence (AI) is making a remarkable impact,.. - [Clinical Study](https://smartalpha.ai/clinical-study/) — SmartAlpha is starting a clinical study for expanding the high quality dataset of Nerveblox, worlds first... - [Skills Required For Ultrasound-Guided Peripheral Nerve Blocks](https://smartalpha.ai/skills-required-for-ultrasound-guided-peripheral-nerve-blocks/) — For a specialist to carry out an ultrasound-guided nerve block procedure successfully, he or she must be completely proficient... - [Worldwide Usage Of Ultrasound-Guided Peripheral Nerve Blocks](https://smartalpha.ai/worldwide-usage-of-ultrasound-guided-peripheral-nerve-blocks/) — The advancements in ultrasound technology have proven to be of great benefit to the medical industry and its patients... - [Revolutionizing Primary Care and Home Health with SmartAlpha's AI-Powered Musculoskeletal Ultrasound Exam Guidance](https://smartalpha.ai/revolutionizing-primary-care-and-home-health-with-smartalphas-ai-powered-musculoskeletal-ultrasound-exam-guidance/) — SmartAlpha is at the forefront of transforming healthcare through our AI-powered musculoskeletal (MSK) ultrasound technology... - [Advancing Abdominal Ultrasound Imaging with Artificial Intelligence: The SmartAlpha Initiative](https://smartalpha.ai/advancing-abdominal-ultrasound-imaging-with-artificial-intelligence-the-smartalpha-initiative/) — In the dynamic landscape of medical technology, artificial intelligence (AI) is a key player, particularly in the field... - [Advancing Ultrasound AI for Abdominal Imaging](https://smartalpha.ai/advancing-ultrasound-ai-for-abdominal-imaging/) — As ultrasound becomes the first-line tool for diagnosing abdominal conditions, the demand for consistent... - [SmartAlpha MSK AI: Ultrasound AI for Enhanced Joint Imaging](https://smartalpha.ai/smartalpha-msk-ai-ultrasound-ai-for-enhanced-joint-imaging/) — SmartAlpha MSK AI represents a new chapter in ultrasound AI — one where advanced technology... ## Articles (full text) --- ### Putting Expert Knowledge Inside the Ultrasound URL: https://smartalpha.ai/why-we-started-smartalpha/ Date: Thu Oct 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) A patient waiting for an ultrasound scan wants to get examined, understand what is wrong, and know what to do next. For the clinician, each examination takes time and attention, often in an already full schedule. We came together at SmartAlpha because we believed we could help make ultrasound easier to use. The machines had become smaller and the images clearer, but getting the right image and recognizing the anatomy still required considerable experience. We wanted to bring some of that knowledge into the device itself. Our work is to make ultrasound systems [anatomy aware](/solution/). A system that recognizes the structures in an image can help the user find their way during a scan. That is where we see a useful role for ultrasound AI, and where we have focused our work. Companies such as GE HealthCare, Philips, Samsung Healthcare, Butterfly Network, Clarius, FUJIFILM Sonosite, Mindray, United Imaging Healthcare, and Siemens Healthineers are working to embed AI into their ultrasound systems. We also aim to partner with them to make our [ultrasound AI solutions](/solution/) available to clinics worldwide sooner than we could reach them on our own. We see this work becoming increasingly relevant to robotic ultrasound too. A robot needs information about the anatomy in view and whether it has acquired the image needed for the examination. We want our AI to support that development. There is plenty of work ahead. Recognizing anatomy is one part of an examination, and each application needs careful development and clinical validation. We are building towards systems that can assist throughout more of the scan, reducing the effort and time required from the user. We want this work to help more people benefit from ultrasound, with less waiting and better support for the clinicians providing it. --- ### SmartAlpha Receives Second FDA Clearance Within a Year: MSK Go™, the Musculoskeletal Ultrasound AI URL: https://smartalpha.ai/smartalpha-receives-second-fda-clearance-within-a-year-for-msk-go-its-musculoskeletal-ultrasound-ai/ Date: Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) - MSK Go™ is an AI-powered software solution designed by SmartAlpha that assists clinicians in performing musculoskeletal (MSK) ultrasound examinations, supporting the assessment of joints, tendons, muscles, and nerves at the point of care. - More than an answer to today's expertise gap, MSK Go is designed as an intelligence layer for the next generation of ultrasound users — whether human or robotic. MSK Go™, an AI software solution by SmartAlpha designed to assist clinicians in interpreting musculoskeletal ultrasound images in real time during the scan, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance marks SmartAlpha's second FDA-cleared ultrasound AI product within one year, following the clearance of Nerveblox™ in 2025, and further establishes the company's presence in the U.S. healthcare market. As the population ages and the strain on health systems grows, musculoskeletal conditions have become one of the heaviest burdens in U.S. healthcare — affecting [more than one in three Americans](https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(23)00235-1/fulltext) and ranking among the largest drivers of healthcare expenditures. Demand for musculoskeletal imaging is rising accordingly, yet a persistent shortage of trained ultrasound experts and sonographers limits access to ultrasound — a modality that can deliver imaging at lower cost, faster, and right at the point of care. MSK Go addresses this challenge with SmartAlpha's broad-coverage anatomy awareness solution: rather than recognizing anatomy only in a handful of predefined scanning windows, the software continuously interprets the ultrasound image as the clinician scans, identifying and highlighting relevant structures — bones, tendons, muscles, nerves, and vessels — wherever the probe is placed across the covered regions. This allows the software to support real-world scanning behavior, with coverage supporting common examinations from carpal tunnel to Achilles tendon to rotator cuff — 120 structures across the body. MSK Go is more than an immediate answer to today's expertise gap — it ushers in the next generation of AI in musculoskeletal ultrasound. Its real-time, edge-ready AI is designed as an intelligence layer for use by human or robotic systems. Commenting on the new product, SmartAlpha co-founder and CEO Utku Kaya stated: "Right after bringing our first solution Nerveblox to clinics globally, we are now announcing the availability of MSK Go for musculoskeletal ultrasound imaging in the United States. But MSK Go also represents something bigger in our vision: an intelligence layer for ultrasound that gives every intelligent healthcare worker, human or robotic, the perception needed to perform ultrasound like experts. Bringing our second cleared solution to market in such a short time shows how determined the SmartAlpha team is to deliver on our vision and ultimately on better patient care." Following the clearance, SmartAlpha will focus on commercializing MSK Go in the U.S. through its distribution partnerships with leading medical imaging vendors, while pursuing integrations with humanoid and medical robotic systems, for which it will seek the required regulatory approvals. ## Disclaimer MSK Go™ is not yet available for sale in all regions worldwide. In regions where MSK Go™ is commercially available, it is intended solely for use by qualified healthcare professionals who are licensed to perform musculoskeletal ultrasound examinations and have been trained in the use of the software, in accordance with local regulations. Use of MSK Go in robotic systems is not within the scope of the current FDA 510(k) clearance, and any such change would be subject to its own regulatory review. --- ### Advancing Ultrasound AI for Abdominal Imaging URL: https://smartalpha.ai/advancing-ultrasound-ai-for-abdominal-imaging/ Date: Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) # Advancing Ultrasound AI for Abdominal Imaging As ultrasound becomes the first-line tool for diagnosing abdominal conditions, the demand for consistent, high-quality imaging and interpretation has never been greater. At SmartAlpha, we believe the future of ultrasound is not just faster — it’s smarter. Our vision is to democratize ultrasound by embedding artificial intelligence into the most routine, yet complex, imaging workflows — including those involving abdominal ultrasound. Abdominal AI refers to the use of artificial intelligence to assist in acquiring, interpreting, and standardizing ultrasound exams focused on the abdominal region. This includes imaging of the liver, gallbladder, kidneys, pancreas, spleen, urinary bladder, abdominal aorta and associated vascular structures, as well as bowel loops and peritoneal fluid evaluation. These structures are frequently assessed in clinical settings for a wide range of conditions — from biliary obstruction and renal pathologies to ascites, hepatomegaly, or abnormal echotexture in liver parenchyma. Yet these exams often depend heavily on the operator’s expertise and patient factors like BMI, making consistency a challenge. At SmartAlpha, we’re committed to building and refining AI-driven technologies that enhance every stage of the abdominal ultrasound workflow: - Probe guidance and view recognition to support consistent capture of key abdominal planes (e.g., longitudinal kidney, transverse gallbladder, subcostal liver views) - Real-time quality scoring based on organ visibility and probe orientation - Organ boundary identification and auto-contour suggestion - Support for biometric measurements such as liver length or kidney size - Assistance with detecting parenchymal texture differences (e.g., steatosis indicators) - Anatomical structure highlighting to improve image interpretation By combining real-time feedback with AI-powered visual cues, SmartAlpha’s approach enables clinicians to standardize abdominal ultrasound exams, even in varied clinical environments. Our abdominal ultrasound AI is aiming to assisst real-world applications — where time is limited, patients vary, and every scan matters. Whether it’s a routine gallbladder exam, kidney ultrasound for hydronephrosis, or screening for fatty liver disease, AI allows us to reduce variability, improve scanning efficiency, support early detection, empower more healthcare professionals to perform high-quality scans. And because SmartAlpha’s AI operates fully within the ultrasound system, it aligns with our privacy-first, cloud-free philosophy. No data leaves the device. No internet is required. That’s how we help healthcare systems scale ultrasound — responsibly. While today’s AI enhances visualization and scanning, our future focus includes deeper, diagnostic support — especially for ultrasound-driven fatty liver grading, organ morphology assessment, and risk pattern analysis in abdominal organs. SmartAlpha is committed to expanding ultrasound AI across the entire abdominal domain, creating tools that complement — not replace — clinical expertise. Our work spans both the technological and clinical dimensions of ultrasound, ensuring every advancement supports better care delivery. SmartAlpha brings together experts in artificial intelligence, software engineering, and medical imaging to shape the next generation of ultrasound AI. Our goal is simple: Make high-quality abdominal ultrasound accessible, consistent, and scalable — everywhere. From point-of-care clinics to global screening programs, abdominal AI can play a pivotal role in unlocking earlier insights and faster decisions. **Regulatory Notice:** SmartAlpha’s abdominal AI technologies are currently under development and are not yet cleared or approved for clinical use in any jurisdiction. The features and capabilities described in this article are intended to illustrate SmartAlpha’s research direction and product vision. Any future use of these technologies in clinical practice will be subject to applicable regulatory approvals, including those from authorities such as the FDA, CE Notified Bodies, or other relevant national agencies. --- ### SmartAlpha MSK AI: Ultrasound AI for Enhanced Joint Imaging URL: https://smartalpha.ai/smartalpha-msk-ai-ultrasound-ai-for-enhanced-joint-imaging/ Date: Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) # SmartAlpha MSK AI: Ultrasound AI for Enhanced Joint Imaging **SmartAlpha MSK AI represents a new chapter in ultrasound AI — one where advanced technology supports clinical clarity, without compromising control.** Ultrasound AI is redefining the way musculoskeletal (MSK) imaging is performed, enabling more consistent visualization of anatomy and empowering clinicians during everyday joint assessments. At SmartAlpha, we’re advancing this transformation with our MSK-focused AI solution — a real-time imaging assistant designed to enhance musculoskeletal ultrasound examinations across various healthcare settings. **What is SmartAlpha MSK AI?** SmartAlpha MSK AI is a software-only medical device that integrates directly into compatible ultrasound systems to assist with joint-focused musculoskeletal imaging. It leverages artificial intelligence to highlight anatomical structures in real-time, offering visual feedback that supports clinical judgment. This AI solution provides automatic segmentation of structures such as tendons, ligaments, cartilage, nerves, and bursae. Visual cues, including semi-transparent overlays, anatomical name labels, and quality scores, guide the user toward optimal probe positioning and scanning technique. **Real-Time, Intelligent Visual Feedback** Once activated, SmartAlpha MSK AI: - Real-time anatomical segmentation with color overlays - Name labeling of each anatomical structure - Image quality scoring of the view - Scan-side feature guidance for consistent probe handling - Automatic measurement assistance in supported views - Fully offline operation, ensuring patient data privacy - Integration with compatible ultrasound systems for seamless use Whether performing a shoulder scan or assessing the knee, the software responds dynamically to live imaging conditions, offering immediate visual guidance tailored to the joint and scanning view. **Broad Joint Coverage, Clinically Relevant Guidance** SmartAlpha MSK AI supports imaging across five high-use joint areas: - Shoulder - Elbow - Hand & Wrist - Knee - Foot & Ankle Each joint is supported with specific anatomical structures and standard scanning views. During a scan, the software offers real-time feedback on anatomical completeness and alignment. **Built for Privacy and Seamless Integration** Unlike many AI solutions, SmartAlpha MSK AI is designed to operate entirely within the ultrasound system — with no need for internet access, cloud services, or external data exchange. The software does not store, transfer, or process any patient-identifiable data, ensuring full compliance with global data protection expectations. Its AI models are “locked,” meaning they do not learn or adapt after deployment, making performance predictable and consistent in clinical use. **Next Move — SmartAlpha MSK Diagnostic Engine** Today, SmartAlpha MSK AI is intended to assist healthcare professionals by enhancing anatomical visualization. It does not provide diagnoses or interpret pathological findings. However, we’re already looking ahead. SmartAlpha MSK Diagnostic Engine is in development as a future-generation platform designed to go beyond visual guidance. It aims to assist clinicians not only in identifying anatomy — but in recognizing clinically significant patterns and suggesting potential diagnostic insights from MSK ultrasound scans. This advanced engine will combine: - AI-based anatomical analysis - Pattern recognition for pathological indicators - Risk stratification assistance based on image features - Context-aware interpretation support SmartAlpha MSK Diagnostic Engine is being developed with a commitment to clinical rigor, transparency, and explainability, and will undergo comprehensive validation and regulatory approval processes prior to any clinical use. **Designed for Global Use, Undergoing Regulatory Review** SmartAlpha MSK AI is currently undergoing regulatory evaluations for use in global markets, including the United States and Europe. Its use in clinical practice is subject to local regulatory clearance. This article is intended to describe the technical capabilities and intended functions of the device, and does not imply regulatory approval or availability in all regions. SmartAlpha MSK Diagnostic Engine is not yet cleared or approved for clinical use. It is under development and subject to regulatory evaluation. This statement is intended as a preview of future directions and does not represent product availability or performance claims. --- ### Introducing SmartAlpha Co-Pilot: Revolutionizing Ultrasound Exams with AI Technology URL: https://smartalpha.ai/introducing-smartalpha-co-pilot-revolutionizing-ultrasound-exams-with-ai-technology/ Date: Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) ## Introducing SmartAlpha Co-Pilot: Revolutionizing Ultrasound Exams with AI Technology **SmartAlpha Co-Pilot** is set to transform the way medical professionals conduct and interpret ultrasound exams, bringing unparalleled efficiency and accuracy to the process. The SmartAlpha Co-Pilot is a cutting-edge ultrasound guidance technology that features a bottom-up proprietary ultrasound language engine. Unlike traditional large-language model (LLM) based solutions, this medical-grade, ultrasound-native technology is the first of its kind, offering unmatched precision and reliability. It is use-case agnostic and initially integrated to enhance SmartAlpha's Musculoskeletal and Abdominal anatomy guidance solutions. In a video showcasing a carpal tunnel exam, the SmartAlpha Co-Pilot demonstrates its ability to redefine the ultrasound user experience. The video highlights how this innovative program enhances workflow efficiency and sets a new standard for medical imaging, driving its widespread adoption. The SmartAlpha Co-Pilot represents a significant leap forward in medical technology and patient care. As we unveil this groundbreaking program, we invite medical professionals and healthcare institutions to join us on this journey towards a brighter future in healthcare innovation.
*The technology shall not be considered available in all regions.* --- ### Advancing Abdominal Ultrasound Imaging with Artificial Intelligence: The SmartAlpha Initiative URL: https://smartalpha.ai/advancing-abdominal-ultrasound-imaging-with-artificial-intelligence-the-smartalpha-initiative/ Date: Mon Jan 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) ## Advancing Abdominal Ultrasound Imaging with Artificial Intelligence: The SmartAlpha Initiative In the dynamic landscape of medical technology, artificial intelligence (AI) is a key player, particularly in the field of abdominal ultrasound imaging. SmartAlpha, a leader in this transformative era, is innovating in AI integration for ultrasound diagnostics, aiming to significantly improve accuracy and patient outcomes in the imaging of liver, kidney, spleen, gallbladder, and other abdominal organs. ##### AI’s Growing Influence in Abdominal Ultrasound AI is reshaping abdominal ultrasound imaging at an impressive pace. SmartAlpha is at the forefront of this evolution, focusing on ultrasound guidance and interpretation for essential abdominal organs. Our cutting-edge AI technology is making strides in medical imaging for abdominal health, paving the way for FDA approval. ##### SmartAlpha: Redefining AI in Abdominal Ultrasound In AI-enhanced abdominal ultrasound imaging, SmartAlpha is a trailblazer, elevating the standards of precision in image interpretation, especially for critical organs like the liver and kidney. ##### The Pioneering Spirit of SmartAlpha in the Ultrasound AI Sector As a pioneering force in the ultrasound AI market, SmartAlpha leverages its expertise and global feedback to innovate in this space. Our commitment to developing a comprehensive, clinically validated AI Software as a Medical Device (SAMD) for abdominal ultrasound applications sets us apart. We are dedicated to pushing the boundaries of what’s possible in healthcare technology, with a keen focus on regulatory compliance and clinical validation. ##### Broadening Clinical Workflows with SmartAlpha’s AI Research indicates that AI can transform clinical workflows in abdominal ultrasound, enhancing image quality and efficiency. SmartAlpha’s AI technology is at the forefront of this transformation, improving the accuracy and efficacy of abdominal imaging procedures. ##### SmartAlpha’s Diverse AI Portfolio in Ultrasound Imaging SmartAlpha has a rich history of developing innovative AI solutions in various ultrasound domains. Our previous products include Nerveblox for regional anesthesia, AI solutions for musculoskeletal joint exams, and AI for urology, all built using one of the world’s most advanced production pipelines. These products exemplify our ability to deliver sophisticated and effective AI solutions across different medical imaging needs. ##### Shaping the Future of Abdominal Ultrasound with SmartAlpha SmartAlpha is dedicated to enhancing the experiences of clinicians and patients in abdominal ultrasound imaging. We are committed to merging precision, efficiency, and the latest technology to set new global standards in medical imaging for abdominal health. In summary, SmartAlpha is spearheading a transformative wave in healthcare technology with a focus on AI-powered abdominal ultrasound imaging. Our expertise in AI, combined with global feedback and a diverse product portfolio, positions us not just as a leader in advancements but as a pioneer of a new era in ultrasound diagnostics. With SmartAlpha, the future of abdominal ultrasound imaging is evolving to be smarter and more efficient than ever before. --- ### AI for Regional Anesthesia Receives CE Marking Approval URL: https://smartalpha.ai/ai-for-regional-anesthesia-receives-ce-marking-approval/ Date: 26/05/2021 # AI for Regional Anesthesia Receives CE Marking Approval *26/05/2021* SmartAlpha announces that Nerveblox, the artificial intelligence driven image interpretation software designed to assist ultrasound-guided peripheral nerve blocks, has recently received CE marking approval. This certifies that Nerveblox was developed in accordance with strict medical standards and the final AI product conforms to related European medical device directives. “Ultrasound devices are getting more and more available with their reduced cost and size, thereby ultrasound-guided interventions have seen immense growth in popularity. We clearly see increased acceptance and adoption of ultrasound usage in new use cases. This situation justifies the growing attention of physicians for our AI-driven ultrasound interpretation software. Imagine how much easier their job become if a non-radiologist physician has AI to help them more readily visualize anatomical structures during an ultrasound. “says Utku Kaya, CEO of SmartAlpha, a Turkey based AI-in-healthcare start-up founded in 2019. Nerveblox is designed to capture real-time images from any ultrasound device. Once the physician starts the ultrasound scan, its patented algorithm gives real-time feedback on image correctness while highlighting and labelling the required anatomical structures. Nerveblox can both be used on a standalone hardware unit or deployed on suitable ultrasound devices. With this certification, SmartAlpha was named as one of the few AI-on-ultrasound products in European market. --- ### Nerveblox™, the Ultrasound AI for Regional Anesthesia Receives FDA Clearance URL: https://smartalpha.ai/nerveblox-the-ultrasound-ai-for-regional-anesthesia-granted-fda-clearance/ Date: Sun Aug 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) ## Nerveblox™, the Ultrasound AI for Regional Anesthesia Receives FDA Clearance - *Nerveblox™ is an AI-powered software that assists in performing ultrasound-guided regional anesthesia, enhancing pain management during and after surgery, as well as in patients with acute or chronic pain.* - *Detects and highlights 50 key anatomical structures across twelve anatomical regions.* Ankara, August 18th Nerveblox™, an AI software solution by SmartAlpha, designed to assist physicians in using ultrasound while administering regional anesthesia to perform a procedure commonly known as ‘nerve block’, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This clearance opens the door for SmartAlpha to launch its technology to the U.S. healthcare market at a time when AI’s role in medicine is more relevant than ever. Nerve block procedures help physicians numb a localized region by injecting anesthetics for managing both surgical and chronic pain. Performed under ultrasound imaging, nerve block procedures enable effective pain management that may lead to faster recovery, shorter hospital stays, and quicker return to normal activities while potentially decreasing the need for opioids. With the ability to detect and highlight 50 key anatomical structures, Nerveblox software assists healthcare professionals by identifying and displaying anatomy in real time during ultrasound scanning for nerve block procedures. It spans a broad range of nerve block procedures relevant to clinical practice from cesarean sections and breast surgery to knee and shoulder procedures, as well as pain relief for fractures and injuries. “By harnessing AI, we can elevate procedural decision-making to enhance accuracy, and accelerate the adoption of ultrasound-guided pain relief strategies that improve patient outcomes,” said Dr. Gary Schwartz, MD, FASA, FASRA, Director of AABP Integrative Pain Care and Wellness. “Having utilized the Nerveblox technology at our research center and contributed to the pivotal trial, I have seen firsthand the potential of this technology to advance precision and safety of interventional ultrasound.” Commenting on the FDA clearance, SmartAlpha co-founder Utku Kaya stated, “Ultrasound guidance is increasingly used for nerve blocks since it maximizes block success and minimizes risk of complications. SmartAlpha is supporting this adoption, and with this clearance, we have taken a significant step forward in SmartAlpha’s mission of delivering AI solutions that assist healthcare professionals worldwide in performing ultrasound imaging with greater ease and confidence.” SmartAlpha is now focused on scaling commercialization in new markets and building strong partnerships to ensure the Nerveblox™ solution effectively reaches healthcare providers around the world. Nerveblox™ has also been granted regulatory approvals in Europe, UK and Australia earlier in 2025. ##### **About SmartAlpha** SmartAlpha is a Turkey-based startup with growing operations in the U.S. and Europe, dedicated to expanding the use of ultrasound by delivering advanced medical skills through clinically proven and regulatory-cleared ultrasound AI. Today, the company operates with a team of 20+ engineers and clinical specialists, working in close collaboration with world-renowned physician advisors, and partners with leading global medical imaging vendors through whom its products are distributed to markets worldwide. ##### **Disclaimer** Nerveblox™ is not yet available for sale in all regions worldwide. In regions where Nerveblox™ is commercially available, it is intended solely for use by qualified healthcare professionals who are licensed to perform ultrasound-guided regional anesthesia procedures and have been trained in the use of the software, in accordance with local regulations. --- ### SmartAlpha Partners with Siemens Healthineers to advance AI-powered Workflow Efficiencies in Ultrasound URL: https://smartalpha.ai/smartalpha-partners-with-siemens-healthineers-to-advance-ai-powered-workflow-efficiencies-in-ultrasound/ Date: Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) ## SmartAlpha Partners with Siemens Healthineers to advance