NEWS RELEASE: Densitas and Leeds Teaching Hospitals sign partnership to bring innovative, personalized breast screening technologies into their routine clinical workflow
510(k) clearance of Densitas’ advanced machine learning algorithm empowers radiologists with on-demand actionable information at point-of-care
VIENNA, Austria – March 1 2018 – Breast imaging analytics innovator Densitas Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its machine learning breast density assessment software. The software empowers radiologists with standardized, personalized and automated density reports to optimize women’s breast health and follow-up care decisions. “Receiving 510(k) clearance marks a significant milestone in our company’s growth as we expand our global reach into the U.S. market with our flagship product,” said Mohamed Abdolell, CEO of Densitas. We are delighted to be entering the largest medical device market in the world, especially as 31 states have passed mandatory breast density notification laws.” Breast density has been shown to be strongly associated with cancer risk. Densitas has the distinct advantage of facilitating breast density assessments of routinely stored standard processed images and their priors because the technology processes the same standard digital mammograms that radiologists view. This provides a practical solution for integrating breast density into risk-based models in population-based screening. The software is cleared for clinical use in the U.S., Europe, Canada and Australia, and is the first of several follow-on products. The software is being showcased at the European Congress of Radiology (ECR 2018), booth 114 at the Austria Center Vienna. About Densitas Densitas develops advanced imaging analytics technologies powered by machine learning that deliver actionable insights at point-of-care for personalized breast health. Our products address the key challenges facing breast imaging today, including mammography quality, workflow efficiencies, compliance with national guidelines and standards, and delivery of appropriate care at sustainable costs. For more information, visit www.densitas.health. Contact Alex Morris [email protected] Mobile: 1-647- 470-4363]]>See original story here Breast imaging analytics innovator Densitas Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its machine learning breast density assessment software. The software empowers radiologists with standardized, personalized and automated density reports to optimize women’s breast health and follow-up care decisions.“Receiving 510(k) clearance marks a significant milestone in our company’s growth as we expand our global reach into the U.S. market with our flagship product,” said Mohamed Abdolell, CEO of Densitas. We are delighted to be entering the largest medical device market in the world, especially as 31 states have passed mandatory breast density notification laws.” Breast density has been shown to be strongly associated with cancer risk. Densitas has the distinct advantage of facilitating breast density assessments of routinely stored standard processed images and their priors because the technology processes the same standard digital mammograms that radiologists view. This provides a practical solution for integrating breast density into risk-based models in population-based screening.The software is cleared for clinical use in the U.S., Europe, Canada and Australia, and is the first of several follow-on products. The software is being showcased at the European Congress of Radiology (ECR 2018), booth 114 at the Austria Center Vienna.About Densitas Densitas develops advanced imaging analytics technologies powered by machine learning that deliver actionable insights at point-of-care for personalized breast health. Our products address the key challenges facing breast imaging today, including mammography quality, workflow efficiencies, compliance with national guidelines and standards, and delivery of appropriate care at sustainable costs. For more information, visit www.densitas.health]]>
See original article here DM-Density personalized breast density reporting software will be offered via vendor neutral artificial intelligence distribution platform Chicago, IL – November 26, 2017 – Advanced breast imaging analytics provider, Densitas, today announced that it now offers its automated breast density software through EnvoyAI’s scalable distribution platform to facilitate streamlined deployment of its flagship product within hospital networks and clinics. The software, DM-Density, helps radiologists provide tailored, patient-specific follow-up care. “We’re pleased to offer hospitals and physicians the opportunity to use Densitas’ breast density software either on-premise or in the cloud. We’re committed to providing our customer base with secure access to innovative AI products globally,” said Misha Herscu, CEO, EnvoyAI. “Densitas’ breast density software is a welcome addition to the many clinically useful applications available on the EnvoyAI Exchange.” “We’re pleased to partner with EnvoyAI to streamline deployment of our automated breast density software to empower health systems to standardize high quality care for women and improve workflow,” said Mohamed Abdolell, CEO, Densitas. “The EnvoyAI platform provides a unique opportunity to rapidly expand our footprint so these important outcomes can be achieved.” DM-Density is a machine learning application that provides on demand automated breast density assessments at point-of-care. The software analyzes standard digital mammograms and integrates seamlessly with PACS systems. The reports provide radiologists with insights to make better follow-up care decisions consistently and confidently. About Densitas Densitas develops machine learning technologies that deliver actionable information for personalized breast health. The technologies address the key challenges facing breast screening, including mammography quality, workflow, compliance and costs, with the aim of improving patient health efficiently and effectively. Densitas has received regulatory clearance to sell its automated breast density assessment software in Canada and the European Union. Learn more. About EnvoyAI EnvoyAI provides a developer platform, integrations, and an API interface for algorithm developers, technology partners, and end users. EnvoyAI facilitates the streamlined distribution and hospital implementation of trained machine learning algorithms via a vendor neutral distribution platform. The platform allows users anywhere to access cloud-based algorithms without requiring access to the algorithm code or training data to protect PHI and developer intellectual property. EnvoyAI assists research institutions and emerging AI companies in the translation and commercialization processes, starting with rapid deployment via a scalable, secure, cloud-based infrastructure with the ability to add local components to facilitate on-site deployments as well. EnvoyAI also works with distribution partners to make algorithms on the platform available to a very wide footprint of hospitals and, ultimately, to physicians. www.envoyai.com Media Contact:Alex MorrisDirector, Programs and Regulatory Affairs Densitas [email protected] 647-470-4363]]>