iCAD Announces FDA Clearance for ProFound AI Version 3.0 for 3D Mammography

Rhea-AI Summary

iCAD announced FDA clearance for ProFound AI Version 3.0 for Digital Breast Tomosynthesis, enhancing algorithm specificity by 10% and processing speed by 40%. This third generation AI solution aids in the detection of malignant lesions, improving efficiency for radiologists. Developed using over 5 million images, this software aims to reduce false positives while maintaining cancer detection rates. The CEO highlighted the significance of these advancements in cancer detection, emphasizing the potential for improved clinical decision-making.

Positive

• FDA clearance for ProFound AI Version 3.0, enhancing algorithm specificity by 10% and sensitivity by 1%.
• Up to 40% faster processing on the new PowerLook platform.
• Developed using over 5 million images, validating robust algorithm performance.
• Significant reduction in false positives, enhancing patient experience.

Negative

• None.

Company’s third generation AI solution offers significant improvement in algorithm specificity performance and faster processing compared to previous versions of the software

Deep learning technology builds upon iCAD’s established leadership in mammography AI

NASHUA, N.H., March 15, 2021 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI^® Version 3.0 for Digital Breast Tomosynthesis (DBT) was cleared by the U.S. Food and Drug Administration (FDA). Compared to previous versions of the software, the ProFound AI 3.0 algorithm offers up to a 10% improvement in specificity performance and up to 1% improvement in sensitivity.¹ ProFound AI Version 3.0 also offers up to 40% faster processing on the new PowerLook platform.¹

“The FDA Clearance of ProFound AI Version 3.0 is yet another milestone that positions iCAD and our technology as vanguards in the cancer detection realm. Our third generation AI solution for DBT may afford physicians the ability to interpret an increasing amount of data in DBT cases and analyze each image to detect malignant lesions more efficiently and with even greater precision,” said Michael Klein, Chairman and CEO of iCAD. “Improvements in specificity, which correlates with reductions in false positives, typically come at the expense of sensitivity and cancer detection scores. To increase sensitivity while simultaneously improving specificity is a huge performance achievement.”

ProFound AI for DBT is a high-performance, deep-learning, workflow solution trained to detect malignant soft tissue densities and calcifications. It became the first 3D tomosynthesis software using artificial intelligence (AI) to be FDA cleared in December 2018.

Built with the latest in deep-learning technology, ProFound AI for DBT rapidly analyzes each tomosynthesis image, detecting malignant soft tissue densities. Certainty of Finding and Case Scores are relative scores computed by the ProFound AI algorithm and represent its confidence that a detection or case is malignant. The Certainty of Finding scores help radiologists by aiding in clinical decision making. Case Scores, which are assigned to each case by the algorithm, help clinicians to gain a sense of case complexity, which may be useful for prioritizing the reading work list.

ProFound AI Version 3.0 was developed using over five million images from 30,000 cases, including almost 8,000 biopsy-proven cancers, and validated on approximately one million images from 3,500 cases that included 1,200 biopsy-proven cancers.

“Late last year we made the decision to go enterprise-wide with ProFound AI,” said Alexander Sardiña, MD, Chief Medical Officer for Solis Mammography. “From a patient perspective, improved specificity and sensitivity means that we can minimize the anxiety caused by false positives and recalls, without compromising cancer detection rates. This is a significant achievement. We’re excited to put this technology to work – on behalf of our patients – across our national network of facilities.”

In a reader study published in Radiology: Artificial Intelligence, ProFound AI for DBT Version 2.0 was shown to offer clinically proven time-savings benefits to radiologists, reducing reading time by 52.7 percent, improving radiologist sensitivity by 8 percent, and reducing false positives and unnecessary patient recall rates by 7.2 percent.²

iCAD’s Breast Health Solutions suite also includes ProFound AI for 2D Mammography, ProFound AI Risk, the world’s first and only clinical decision support tool that provides an accurate two-year, breast cancer risk estimation that is truly personalized for each woman, based only on a screening mammogram,³ and software to evaluate breast density.

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com and www.xoftinc.com.

Forward-Looking Statements

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the benefits of the Company’s agreement with Solis and future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve business and strategic objectives, the willingness of patients to undergo mammography screening in light of risks of potential exposure to Covid-19, whether mammography screening will be treated as an essential procedure, whether ProFound AI will improve reading efficiency, improve specificity and sensitivity, reduce false positives and otherwise prove to be more beneficial for patients and clinicians,  the impact of supply and manufacturing constraints or difficulties on our ability to fulfill our orders, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights,  product market acceptance, possible technological obsolescence of products, increased competition, government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov. 

Contacts:
Media inquiries:
Jessica Burns, iCAD  
+1-201-423-4492
jburns@icadmed.com

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1-212-915-2568
jeremy@lifesciadvisors.com

____________________________

¹ *iCAD data on file. Standalone performance varies by vendor. FDA Cleared.
² Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096
³ Eriksson M, Czene K, Strand F, et al. Identification of Women at High Risk of Breast Cancer Who Need Supplemental Screening. [published online ahead of print September 8, 2020]. Radiology. Accessed via https://doi.org/10.1148/radiol.2020201620

FAQ

What is ProFound AI Version 3.0 from iCAD?

ProFound AI Version 3.0 is an AI solution for Digital Breast Tomosynthesis, offering enhanced specificity and sensitivity for cancer detection.

What improvements does ProFound AI Version 3.0 provide?

It offers a 10% improvement in specificity and a 1% improvement in sensitivity, along with 40% faster processing.

When was ProFound AI Version 3.0 cleared by the FDA?

ProFound AI Version 3.0 was cleared by the FDA on March 15, 2021.

How does ProFound AI benefit radiologists?

It aids radiologists by minimizing false positives and enhancing efficiency in detecting malignant lesions.

What data was used to develop ProFound AI Version 3.0?

It was developed using over 5 million images from 30,000 cases, including nearly 8,000 biopsy-proven cancers.