Mar 2, 2018 | Densitas Inc., News
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.
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Alex Morris
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Mobile: 1-647- 470-4363]]>
Mar 1, 2018 | Densitas Inc., Members, News
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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]]>
Feb 27, 2018 | Densitas Inc., News
See original story here
Densitas Inc. announced today that it has received regulatory clearance for its automated breast density software, DM-Density. DM-Density has received regulatory clearance from the Australian Therapeutic Goods Administration (TGA) and will be available through the EnvoyAI Platform.
Australia has approximately 12 million women and 1.7 million are screened for breast cancer using mammography every two years. Breast cancer is the most commonly diagnosed cancer in Australian women aged 50-74, with 300 new cases for every 100,000 women. Breast cancer is the second most common cause of cancer mortality in Australian women aged 50-74, with approximately 45 deaths per 100,000 women. The Australian Government has increased its commitment to the early detection of breast cancer by recently expanding the BreastScreen Australia target age to include women 70-74.
Phillip Cahill, Director of Diagnostic Imaging Australia, EnvoyAI’s Australian distributor, will launch DM-Density into the Australian market. “We are pleased to be able to offer Densitas’ software in Australia, as it fills a need for radiologists looking for a reliable and standardized breast density solution.
Densitas automatically reads and categorizes each mammogram, determining a patient’s breast density category, in a matter of a few seconds. The deployment of the Densitas algorithm on the Envoy AI platform is a natural fit that radiologists will find to be seamless,” said Mr. Cahill.
“We are excited that doctors and patients in Australia can now benefit from our advanced machine learning algorithms to assess breast density,” said Mohamed Abdolell, CEO of Densitas. “Our entry into the Australian market marks further expansion of our technology globally.”
About Densitas (www.densitas.health) Densitas develops advanced imaging analytics technologies powered by machine learning that deliver actionable insights at point-of-care for high quality 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.
About EnvoyAI (www.envoyai.com) EnvoyAI facilitates the streamlined distribution and hospital implementation of trained machine learning algorithms via a vendor neutral distribution platform. EnvoyAI provides a developer platform, integrations, and an open API for algorithm developers, technology partners, and end users. EnvoyAI also works with distribution partners to make algorithms on the platform available to a wide footprint of hospitals and, ultimately, to physicians.
ContactAlex Morris]]>
