Public Health


FDA Clears Subtle Medical's AI-Powered Image Enhancement Software

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Subtle Medical today announced its artificial intelligence (AI)-powered image processing software, SubtleMR, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). SubtleMR uses deep learning algorithms, denoising and resolution enhancement to improve the image quality of existing scanners. "We are pleased to received FDA clearance for SubtleMR, and we look forward to helping radiology departments and imaging centers get the most out of their existing MRI scanners," said Enhao Gong, Ph.D., founder and CEO of Subtle Medical. The software, which Subtle Medical said is compatible with any brand of MRI scanner and picture archiving and communication systems (PACS), could be beneficial for patients who have trouble staying still for long periods of time. Reducing the scan time for these patients not only improves the patient experience but could result in fewer artifact-ridden images and the need for physicians to re-scan an individual.


Canon Medical's Ultra-High Resolution CT Receives FDA Clearance for Artificial Intelligence-Based Image Reconstruction Technology BioSpace

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WIRE)-- Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced Intelligent Clear-IQ Engine (AiCE) for the Aquilion PrecisionTM further expanding access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE / GENESIS EditionTM premium CT systems, uses a deep learning algorithm to differentiate signal from noise so that it can suppress noise while enhancing signal, forging a new frontier for CT image reconstruction. Aquilion Precision - the world's first Ultra-High Resolution CT provides 2 times the resolution of conventional CT, revealing detail that is typically only seen in Cath labs. With AiCE, the system now enables clinicians to perform super-high resolution studies at doses equivalent to standard resolution CT (with traditional hybrid iterative reconstruction techniques). AiCE learns from the high image quality of Model Based Iterative Reconstruction (MBIR) to reconstruct CT images with improved high contrast spatial resolution*.


Subtle Medical Receives FDA 510(K) Clearance for AI-Powered SubtleMR

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"One of the most exciting things about deep learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," said Christopher Hess, MD, Chair of the Department of Radiology and Biomedical Imaging at UCSF. SubtleMR delivers a significant improvement in the quality of noisy images, which is particularly beneficial for patients who have difficulty holding still for long periods of time. Artifact-ridden images and the need for re-scans are a challenge for both patients and physicians. SubtleMR integrates seamlessly into the radiology workflow, and it is compatible with any brand of MRI scanner and PACS.



Intelerad, Zebra Medical Vision Partner to Accelerate AI Adoption for Radiologists

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After expanding its "all-in-one" AI bundle, which includes 3 FDA 510(k) clearances, the deep learning medical imaging analytics company, Zebra Medical Vision, is now announcing a new joint partnership with Intelerad Medical Systems, a leader in enterprise workflow solutions. The joint program will leverage Intelerad's newly released Odyssey designed to encourage the adoption of artificial intelligence without the prohibitive costs usually associated with such programs. The positive impact of artificial intelligence technology has been demonstrated in many fields, including that of radiology. Indeed, AI can help radiologists increase productivity, improve clinical decisions and, ultimately, provide high-quality care when the technology is tightly managed and smartly integrated in the workflow. Odyssey harnesses the power of artificial intelligence and the technology behind the Intelerad worklist to offer an unparalleled workflow management solution, comprised of the clinical AI engine, powered by Zebra-med's AI1 "all-in-one" bundle of FDA cleared AI applications.


Adopting AI in Health Care Will Be Slow and Difficult

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Artificial intelligence, including machine learning, presents exciting opportunities to transform the health and life sciences spaces. It offers tantalizing prospects for swifter, more accurate clinical decision making and amplified R&D capabilities. However, open issues around regulation and clinical relevance remain, causing both technology developers and potential investors to grapple with how to overcome today's barriers to adoption, compliance, and implementation. Over the past few years, the U.S. Food and Drug Administration (FDA) has been taking incremental steps to update its regulatory framework to keep up with the rapidly advancing digital health market. In 2017, the FDA released its Digital Health Innovation Action Plan to offer clarity about the agency's role in advancing safe and effective digital health technologies, and addressing key provisions of the 21st Century Cures Act.


Merck turning to machine learning to prevent drug shortages: Merck plans to use a cloud-based software platform to better predict and prevent drug shortages, according to The Wall Street Journal.

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Merck plans to use a cloud-based software platform to better predict and prevent drug shortages, according to The Wall Street Journal. The platform, developed by healthcare software company TraceLink, will analyze in real time data from pharmacies, hospitals and wholesale distributors. By using analytics and machine learning, the software can improve predictions and help drugmakers better match drug demand. The software could also save drugmakers hundreds of millions of dollars annually by reducing waste and avoiding costs like expedited shipments, because it can track a drug's status at every step in the supply chain. The platform currently holds data on more than 6 billion drugs.


Subtle Medical Receives FDA 510(k) Clearance for AI-Powered SubtleMR

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"One of the most exciting things about deep learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," said Christopher Hess, MD, Chair of the Department of Radiology and Biomedical Imaging at UCSF. SubtleMR delivers a significant improvement in the quality of noisy images, which is particularly beneficial for patients who have difficulty holding still for long periods of time. Artifact-ridden images and the need for re-scans are a challenge for both patients and physicians. SubtleMR integrates seamlessly into the radiology workflow, and it is compatible with any brand of MRI scanner and PACS.


Omega Medical Imaging First in the World to Receive FDA Clearance on Artificial Intelligence Imaging System that Reduces Dose - Omega Medical Imaging

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Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, just announced the Food and Drug Administration 510 (k) clearance of FluoroShield with their 2020 Cardiac Flat Panel Detector. The unique FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy. The blended image incorporates a lower frequency refresh of the peripheral image area. This combined image (live fluoroscopy or cine of ROI background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures. Brian Fleming, President of Omega Medical Imaging states, "Until now products on the market have only been able to manage radiation to patients and staff. FluoroShield is the only system in the world that provides an actual reduction in dose. The impact of this groundbreaking solution for patients and healthcare providers is substantial. I am very grateful to be a part of a team that pushes the envelope in the development of safer healthcare solutions."


AI for OH: can artificial intelligence change the way we deliver occupational health?

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Artificial intelligence is revolutionising medicine – but can it do the same for occupational health? Occupational physician Dr Steve Boorman considers the opportunities and challenges of adopting AI systems in OH. Having spent the past few years of my career working in a technology company, I have seen at first hand the rapid developments in hardware and software that are changing the way we use and think about machines. Machine learning and artificial intelligence (AI) are now everyday realities and we would be foolish to think that occupational health (OH) practice will not see change driven by such technology. Gordon E Moore, the co-founder of technology company Intel, observed in 1965 that the number of transistors packed into a given amount of space would double every two years1.