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Yahoo
4 days ago
- Health
- Yahoo
Avicenna.AI Secures CE Mark for Two Spine-Focused Medical Imaging AI Tools
EU certification granted for AI algorithms for vertebral compression fracture quantification and cervical spine fracture detection. MARSEILLE, France, June 5, 2025 /PRNewswire/ -- Medical imaging AI company today announced that it has received CE Mark certification for CINA-VCF Quantix, a new AI algorithm designed to detect and assess unsuspected vertebral compression fractures (VCFs) in patients undergoing CT scans for unrelated conditions. The company also secured CE Mark certification for CINA-CSpine, an AI tool designed to detect and triage cervical spine fractures from CT images. The CE mark signifies that both products meet the stringent health and safety standards required by the European Union, enabling them to be deployed across the European Economic Area without additional regulatory barriers. VCFs, often caused by bone deterioration due to osteoporosis, can lead to significant pain, deformity, and height loss. In the U.S. alone, approximately 750,000 adults suffer osteoporotic VCFs annually, but nearly two-thirds go undiagnosed, increasing the risk of further fractures and complications. CINA-VCF Quantix is intended for patients aged 50 and older undergoing CT scans of the chest and/or abdomen for other conditions. The tool automatically labels vertebrae and calculates vertebral height loss ratios in the thoracic and lumbar spine. If a vertebral height loss ratio exceeds 20%–25%, indicating a moderate to severe VCF, CINA-VCF Quantix generates a passive notification, prompting radiologists to report early findings and supporting proactive patient care. "Osteoporotic vertebral fractures can have a profound impact on patients' quality of life. The launch of CINA-VCF Quantix in Europe represents a major step forward in preventive care, empowering clinicians to intervene before minor fractures escalate," said Cyril Di Grandi, co-founder and CEO of "By encouraging the reporting of VCF presence and severity, CINA-VCF Quantix has the potential to make a real difference in long-term patient outcomes." Cervical spine fractures, typically caused by trauma, involve breaks in one or more of the seven cervical vertebrae in the neck. If the spinal cord is affected, these fractures can cause neurological damage or paralysis. Early diagnosis and treatment are critical to improving outcomes and minimizing long-term complications. CINA-CSpine automatically flags suspected acute cervical spine fractures, alerting radiologists through their existing systems for faster diagnosis and intervention. "The launch of CINA-CSpine in the European market marks a significant step forward in trauma care. By reducing the time between scan and diagnosis, we're helping radiologists catch cervical spine fractures faster and more reliably — a crucial advance when every minute counts," said Di Grandi. "CINA-CSpine serves as a second pair of eyes, enhancing diagnostic confidence and ultimately improving patient outcomes across Europe." All of products are seamlessly integrated into radiologists' clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists. The company's product portfolio also includes AI tools for: Intracranial hemorrhage (CINA-ICH) Large vessel occlusion (CINA-LVO) Aortic dissection (CINA-AD) Pulmonary embolism (CINA-PE and CINA-iPE) Vertical compression fractures (CINA-VCF) And ASPECT Score for quantification of stroke severity (CINA-ASPECTS). About in 2018, specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr. Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore website at View original content: SOURCE
Yahoo
6 days ago
- Health
- Yahoo
Corify Care announces AI collaboration with Mayo Clinic to improve cardiac arrhythmia care
MADRID, June 3, 2025 /PRNewswire/ -- Corify Care, an AI-driven medical technology company specializing in global cardiac mapping and real-time precision guidance for the treatment of cardiac arrhythmias, announced today it has entered into a know-how agreement with Mayo Clinic. Nearly 60 million people worldwide are affected by atrial fibrillation, yet treatment outcomes for complex cases remain ineffective. More than 50 percent of ablation procedures for complex arrhythmia fail, in many cases because clinicians are unable to target the necessary region of the heart. Corify's global mapping technology now allows clinicians to pinpoint the source of an atrial fibrillation case, creating an accurate roadmap for completing a targeted ablation. As part of the collaboration, select Mayo Clinic physicians will help Corify refine its current model and make recommendations on improvements relating to useability and clinical flow. "This collaboration focuses on advancing AI-powered technology for real-time cardiac mapping and enhanced procedural guidance in arrhythmia treatment,'' said Andreu Climent, CEO of Corify Care. Corify Care's proprietary technology offers a global and efficient solution to detect, map, and manage complex cardiac arrhythmias with unprecedented speed and accuracy. Unlike traditional invasive diagnostic methods, Corify Care's system creates detailed three-dimensional maps of the heart's electrical activity — offering a faster approach to arrhythmia diagnosis and management. Ultimately this technology aims to provide more effective treatment and a reduced risk of recurrence, saving and improving more patients' lives. Recent clinical research confirmed that Corify's imageless ECGI system enables noninvasive, real-time cardiac mapping without the need for CT or MRI and can be applied across a wide range of procedures including atrial fibrillation, ventricular tachycardia, and cardiac resynchronization therapy. Corify has earned recognition across Europe for its clinical impact, winning several prestigious awards and receiving support from the European Innovation Institute of Technology. It is pursuing FDA approval after securing CE Mark certification in 2024 under the European Union's Medical Device Regulation. Since its launch, the technology has been successfully used in around 2,000 cases, with adoption continuing to grow. For more information about Corify, please visit Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research Contact: Alex Jackson (shark&minnow) aj@ (216) 245-3477 View original content to download multimedia: SOURCE Corify Care
Yahoo
27-05-2025
- Business
- Yahoo
SS Innovations Surpasses Milestone of 4,000 Robotic Surgeries Successfully Performed with the SSi Mantra Surgical Robotic System
FORT LAUDERDALE, Fla., May 27, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the 'Company' or 'SS Innovations') (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company's SSi Mantra surgical robotic system has been utilized to successfully perform more than 4,000 robotic surgeries across more than one hundred types of surgeries without any complications, injuries or mortalities. Of note, this milestone includes approximately 215 cardiac surgical procedures, of which six were successfully performed via telesurgery across India with the SSi Mantra 3 surgical robotic system. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, 'The milestone of 4,000 robotic surgeries successfully performed with our SSi Mantra surgical robotic system reflects its world-class quality, differentiated features, ease of use, and growing acceptance by leading physicians in India, where SS Innovations leads the market, and beyond. Our SSi Mantra systems are cleared to market in seven countries, and we are taking important steps to enter the United States and European Union markets. We continue along the pathway towards a European Union CE Mark decision as soon as late 2025 and a U.S. Food and Drug Administration decision as soon as the first half of 2026.' Surgery types performed with the SSi Mantra to date: General Surgery Urology Gynecology Cardiac Gastrointestinal Thoracic Head and Neck Breast and Plastic Countries where the SSi Mantra is approved to market: India Nepal Ecuador Guatemala Philippines Indonesia Ukraine About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company's product range includes its proprietary 'SSi Mantra' surgical robotic system and its comprehensive suite of 'SSi Mudra' surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company's website at or LinkedIn for more information and updates. About the SSi Mantra The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures. Forward Looking Statements This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'anticipate,' 'assume,' 'believe,' 'estimate,' 'expect,' 'will,' 'intend,' 'may,' 'plan,' 'project,' 'should,' 'could,' 'seek,' 'designed,' 'potential,' 'forecast,' 'target,' 'objective,' 'goal,' or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations' future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Investor Contact: The Equity Group Kalle Ahl, CFA T: (303) 953-9878 kahl@ Devin Sullivan, Managing Director T: (212) 836-9608dsullivan@ Media Contact:press@ (212) 739-0300Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
ReGelTec's system for disc augmentation gains CE Mark approval
ReGelTec has secured CE Mark approval for the Class III Hydrafil System for disc augmentation, under the European Union Medical Device Regulation (MDR). The approval is based on a clinical trial involving 75 subjects, which revealed that the system's treatment led to significant improvements in disability and pain. According to the findings, an improvement exceeding 80% was observed in Oswestry Disability Index (ODI) scores and a decrease of more than 70% in Numeric Pain Rating Scale scores post-treatment, with sustained results for two years. ReGelTec noted that the system is designed to be an outpatient procedure performed under local anaesthesia. It involves the injection of a permanent hydrogel into a degenerated disc for filling cracks and tears while also recruiting water to restore the disc's natural biomechanics and alleviate pain. Once solidified in the disc, the hydrogel implant helps in distributing the strain and load across the intervertebral segment, enhancing function and decreasing pain signals to the brain. The data that supported this approval also contributed to the US Food and Drug Administration's (FDA) decision to grant an investigational device exemption (IDE) for the company's US pivotal study, HYDRAFIL-D. This single-blinded, 225-patient, randomised, controlled study is actively enrolling subjects across eight sites and aims to support future regulatory approval in the country. The study includes an interim safety analysis scheduled after the first 60 subjects complete their six-month follow-up. ReGelTec's percutaneous hydrogel implant is intended for treating chronic low back pain caused by degenerative disc disease. ReGelTec CEO and co-founder Bill Niland said: 'Receiving CE Mark for the Hydrafil System is another major milestone for ReGelTec. We are leveraging this momentum to drive enrolment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the US and globally.' In June 2023, the company reached an exclusive distribution agreement with BCWorld Healthcare for the system in South Korea. "ReGelTec's system for disc augmentation gains CE Mark approval" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-05-2025
- Health
- Yahoo
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
Clinical data show the percutaneous disc augmentation system generated significant improvements in pain and disability scores through 2-year follow-up BALTIMORE, May 21, 2025--(BUSINESS WIRE)--ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This approval creates a European commercial pathway for the HYDRAFIL System, an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain, improve daily function and eliminate the need for invasive surgeries. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit. "Chronic low back pain is a debilitating condition that impacts millions of people every year. Degenerative disc disease, which is the largest driver of chronic low back pain, is especially challenging to treat and manage because there are limited treatment options between conservative care and more invasive surgeries," said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. "After following 35 patients treated with HYDRAFIL over the last three years, I've witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability. HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery, and we are excited to start enrolling patients in the HYDRAFIL-D U.S. pivotal study." More than 1 in 10 U.S. adults suffer from chronic low back pain.1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease2, a condition which is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL® System injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain. Data used to secure CE Mark also led the FDA to approve an investigational device exemption (IDE) for ReGelTec's U.S. pivotal study of its HYDRAFIL System. The HYDRAFIL-D study is currently enrolling patients at eight sites in the U.S. and will be used to support U.S. regulatory approval. The study is a 225-patient, multicenter, single-blinded, randomized, controlled trial that includes an interim safety analysis when the first sixty patients complete their 6-month follow-up visit. "Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec," said Bill Niland, Co-Founder and CEO, ReGelTec. "We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally." ABOUT REGELTEC, INC: ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL® System is an outpatient disc augmentation procedure where a permanent hydrogel is injected into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit ______________________________ 1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174. 2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233, View source version on Contacts MEDIA CONTACT: Sam ChoinskiPazanga Health Communications(860) 301-5058schoinski@ Sign in to access your portfolio
