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Associated Press
25-03-2025
- Business
- Associated Press
Gleamer Receives FDA Clearance for ChestView, Revolutionizing Chest X-ray Interpretation with CADe in the U.S.
/ -- Gleamer, a leading innovator in artificial intelligence-powered medical imaging solutions, announced today that its advanced chest X-ray interpretation solution, ChestView, has received clearance from the U.S. Food and Drug Administration (FDA). This announcement marks a groundbreaking advancement in chest X-Ray interpretation, with a Computer-Aided Detection (CADe) model cleared by the FDA for simultaneously detecting multiple pathologies, enabling direct highlighting of abnormalities on images. This capability significantly enhances explainability and confidence in diagnoses compared to traditional triage-focused CADt solutions on chest X-rays, setting a new standard in AI-assisted radiological diagnostics. This is Gleamer's second announcement of an FDA clearance, following the successful introduction of BoneView in April 2022, reflecting the expanding footprint of the Gleamer Copilot® suite in the U.S. market. The application is enhanced by a unified UX/UI experience with BoneView, ensuring seamless integration and ease of adoption for healthcare providers. This milestone paves the way for ChestView's immediate launch across the United States, offering healthcare providers a powerful tool for faster, more accurate diagnoses. With the U.S. already contributing 30% of Gleamer's revenue from BoneView, ChestView is expected to significantly accelerate this growth. ChestView leverages cutting-edge artificial intelligence algorithms to assist radiologists and clinicians by automatically detecting key radiological findings in chest X-rays. ChestView further solidifies Gleamer's leadership in AI medical imaging, uniquely covering all core imaging modalities, including X-Ray, Mammography, CT, and MRI. By identifying anomalies such as pleural space abnormalities, lung nodules, and other critical pathologies, ChestView aims to significantly enhance diagnostic accuracy, reduce diagnostic delays, and improve patient outcomes. The introduction of CADe technology, such as ChestView, represents a significant advancement in medical imaging, enabling healthcare providers to manage increasing workloads efficiently, reduce oversight errors, and enhance the overall quality of patient care. 'Securing FDA clearance is a major achievement for Gleamer and underscores our commitment to advancing medical imaging through innovative AI technology. This comes after Gleamer's recent acquisition of FDA-cleared Neuro MRI AI developer, Pixyl, further accelerating our growth and expansion within the U.S. market,' said Christian Allouche, CEO at Gleamer. 'We believe ChestView will transform how chest X-rays are analyzed, making healthcare delivery faster, safer, and more effective for millions of patients.' ChestView has already demonstrated exceptional performance in clinical studies, significantly improving diagnostic sensitivity and reducing time-to-diagnosis. The application integrates seamlessly into existing clinical workflows, providing radiologists with critical insights in seconds. With this FDA clearance, Gleamer is set to roll ChestView out across its existing install-base and partner with new healthcare institutions nationwide, helping clinicians leverage AI to deliver superior patient care. For more information about ChestView and Gleamer's innovative imaging solutions, visit Founded in 2017, Gleamer considers AI to be a key solution for addressing the sharp rise in demand for medical imaging, stemming from the challenges of an ageing population, the increasing prevalence of chronic diseases, and the problems of access to healthcare. The company's suite of AI-powered solutions, across X-Ray, Mammography, CT and now, MRI, supports radiologists and clinicians in their diagnoses, thereby improving reliability and reducing the time taken to read and process examinations. The relevance and exceptional performance of these solutions have been recognised worldwide thanks to 30 publications in highly regarded peer-reviewed journals. With 35 million exams analysed across over 2,000 institutions, spanning 45 countries across all continents, Gleamer's solutions are now widely acclaimed within the medical imaging industry. +44 (0) 7414 903223 Margaret Gagnon Contollo Comms +1 401-207-9370 Legal Disclaimer:
Yahoo
11-03-2025
- Business
- Yahoo
Radiology AI software provider Gleamer expands into MRI with two M&A transactions
Medical imaging is a broad term that encompasses several distinct technologies. After working on AI-powered tools to enhance X-rays and mammographies, French startup Gleamer now aims to tackle magnetic resonance imaging (MRI). Instead of starting from scratch, Gleamer has acquired a startup that has already been working on AI-powered MRI analysis, Caerus Medical, and is merging with Pixyl. Gleamer is part of the second wave of startups trying to improve medical imaging using artificial intelligence. Several tech founders created startups around this topic in 2014 or 2015. While most of them went nowhere, there have been some consolidation in the space. For instance, Zebra Medical Vision and Arterys were both acquired by Nanox and Tempus, respectively. Founded in 2017, Gleamer has been building an AI assistant for radiologists, a sort of copilot for medical imaging. With Gleamer, radiologists can theoretically improve the diagnostic accuracy when interpreting medical images. The startup has already persuaded 2,000 institutions across 45 countries to use its software solution. Overall, Gleamer has processed 35 million examinations. The company has received CE and FDA certifications for its bone trauma interpretation product. In Europe, it also offers products specifically focused on chest X-rays, orthopedic and bone age measurements with CE certification. 'Unfortunately, the one-size-fits-all approach to radiology doesn't work,' Gleamer co-founder and CEO Christian Allouche told TechCrunch. 'It's very complicated to have a large model that covers all medical imaging and delivers the level of performance expected by doctors.' That's why the company created small internal teams focused on mammographies and CT scans. 'Three weeks ago we released our mammography product, which we have been working on for 18 months,' Allouche said. It's based on a proprietary AI model that has been trained on 1.5 million mammographies. 'We have a partnership with Jean Zay, the French government's GPU cluster,' Allouche said. The company is also working on CT scans for cancers. But what about MRI? 'MRI is a different technological space,' Allouche said. 'You have a lot of tasks in MRI. It's not just detection, you've got segmentation, you've got detection, you've got characterization, classification, multi-sequence imaging.' That's why Gleamer is acquiring a small startup (Caerus Medical) and merging with a larger one (Pixyl) to move faster. These two companies have been working in this space for several years. Gleamer isn't disclosing the terms of the deals. 'These two companies will become our two MRI platforms, with the clear ambition of covering all use cases over the next two to three years,' Allouche said. While Gleamer's models show promising results, they are not yet perfect. For example, with the company's new mammography model, the startup claims it can detect four out of five cancers. In comparison, a human radiologist without AI assistance typically identifies cancer in three out of five cases. However, the productivity gains from a tool like Gleamer could radically change medical imaging. A missed tumor is likely to appear in a follow-up exam a few months later. 'In the not-too-distant future, I think we'll all be getting routine whole body MRIs paid for by our insurance companies — since they're not irradiating,' Allouche said. However, in some cities, there are already too few radiologists to meet the demand for reactive imaging. If the industry shifts toward preventive imaging, AI tools will become indispensable. Gleamer's CEO thinks AI could become an 'orchestrating and triaging' tool. Most medical imaging examinations are conducted as a way to rule out some diagnoses. 'So, there's a real need to automate all this with a very solid AI model that has a much higher level of sensitivity than a human,' Allouche said.