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FDA clears iCAD's ProFound AI for DBT | 合法醫療器材資訊網

FDA clears iCAD's ProFound AI for DBT

2021年3月16日—TheFDAhasclearediCAD'sProFoundAIversion3.0fordigitalbreasttomosynthesis(DBT).

 FDA clears iCAD's ProFound AI for DBT

The U.S. Food and Drug Administration (FDA) has cleared computer-aided detection (CAD) software developer iCAD[1]s ProFound artificial intelligence (AI) version 3.0 for digital breast tomosynthesis (DBT).

The updated software improves specificity by 10%, sensitivity by 1%, and processing speed on its PowerLook platform by 40%, the company said.

In 2018, ProFound AI was the first 3D tomosynthesis software to be cleared by the FDA, according to iCAD. The new version was developed on more than 5 million images from 30,000 cases, including 8,000 biopsy-confirmed cancers; it was validated on 1 million images from 3,500 cases that included 1,200 biopsy-confirmed cancers, the company said.

References iCAD (www.auntminnie.com)

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iCAD Announces FDA Clearance for ProFound AI Version 3.0 | 合法醫療器材資訊網
2021年3月15日 — ProFound AI for DBT is a high-performance, deep-learning, workflow solution trained to detect malignant soft tissue densities and calcifications. It ... Read More
iCAD | 合法醫療器材資訊網
2019年10月4日 — iCAD, Inc. ... In addition, FDA may publish further announcements ... ProFound™ AI V2.1 Software is a computer-assisted detection and ... Read More
iCAD Announces FDA Clearance for ProFound AI ... | 合法醫療器材資訊網
2021年3月15日 — “The FDA Clearance of ProFound AI Version 3.0 is yet another milestone that positions iCAD and our technology as vanguards in the cancer ... Read More
iCAD Announces FDA Clearance of ProFound AI™ for Digital ... | 合法醫療器材資訊網
2018年12月7日 — “Obtaining FDA clearance for ProFound AI opens a new and substantial addressable market for iCAD. This enables us to offer clinicians ... Read More
ProFound AI for Digital Breast Tomosynthesis | 合法醫療器材資訊網
ProFound AI for Digital Breast Tomosynthesis (DBT) is FDA cleared to offer superior performance and sensitivity to support radiologists in the fight against breast ... Read More
iCAD Announces FDA Clearance for ProFound AI ... | 合法醫療器材資訊網
2021年3月15日 — ProFound AI for DBT is a high-performance, deep-learning, workflow solution trained to detect malignant soft tissue densities and calcifications. It ... Read More
FDA Clears for ProFound AI Version 3.0 for 3D Mammography ... | 合法醫療器材資訊網
FDA Clears for ProFound AI Version 3.0 for 3D Mammography ... iCad announced that ProFound AI Version 3.0 for Digital Breast Tomosynthesis (DBT) was cleared. Read More
K191994 | 合法醫療器材資訊網
2019年10月4日 — Super Search Devices@FDA 6 ... 510(k) Number, K191994. Device Name, ProFound AI Software V2.1. Applicant. iCAD Inc. 98 Spit Brook Rd. Read More
FDA clears iCAD's ProFound AI for DBT | 合法醫療器材資訊網
2021年3月16日 — The FDA has cleared iCAD's ProFound AI version 3.0 for digital breast tomosynthesis (DBT). Read More
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