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CST: 15/09/2019 20:57:58   

SimonMed Imaging Implements the First FDA-Cleared 3D Tomosynthesis Software Using Artificial Intelligence

67 Days ago

iCAD’s Innovative ProFound AI™ Solution for Digital Breast Tomosynthesis offers high-performing workflow solution for radiologists

PHOENIX and NASHUA, N.H., July 10, 2019 (GLOBE NEWSWIRE) -- SimonMed Imaging, one of the largest outpatient medical imaging providers and largest physician radiology practices in the United States, announced today their implementation of the first FDA-cleared AI program for significantly enhancing early breast cancer detection for 3D mammography. The AI program, called ProFound AI™ for digital breast tomosynthesis (DBT), is a technology developed by iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI for DBT is a high-performance, deep learning, workflow solution that assists radiologists reading mammography. It is the first and only FDA cleared 3D tomosynthesis technology using artificial intelligence.

“Implementing ProFound AI into our processes for breast cancer screenings will improve detection of breast cancer and reduction of false positives and recalls,” said John Simon, M.D., Founder and CEO of SimonMed. “With the enhanced technology available through 3D mammography, the review of the 84 slices of breast tissue per breast will now be expedited, but does not replace the specialized radiologist.”

ProFound AI for DBT was FDA-cleared in 2018 and offers benefits to both radiologists and patients alike. Designed to detect malignant soft-tissue densities and calcifications, the software provides radiologists with key data, such as Certainty of Findings and Case Scores, which can assist radiologists in making clinical decisions and prioritizing caseloads. The technology has been clinically proven to improve cancer detection rates by 8 percent, reduce unnecessary patient recall rates by 7.2 percent, and slash radiologists’ reading time by 52.7 percent and up to 57.4 percent for dense breast 3D image analysis.

“It is exciting to see the momentum generated following the FDA clearance of ProFound AI for DBT and the expansion of our marketplace throughout the SimonMed Imaging enterprise,” said Michael Klein, CEO of iCAD. “This important partnership demonstrates the need for innovative, advanced AI platform solutions to assist radiologists in accurately identifying breast cancer sooner, when it may be more easily treated. SimonMed’s unique nationwide enterprise care model also provides a scalable platform and partnership for future collaboration.”

SimonMed Imaging and its affiliates have been serving local communities throughout the U.S. for over 30 years, with more than 150 convenient locations to accommodate patients. Patients interested in learning more can call or text SimonMed at 1-866-614-8555 to schedule an appointment. For more information about ProFound AI, visit www.icadmed.com or www.simonmed.com.

About SimonMed
SimonMed Imaging is the largest physician owned outpatient radiology practice in the United States and specializes in all major medical fields of medical imaging. Our vision is to change the medical imaging experience with advanced technology, and our mission is to provide high quality, affordable medical imaging to all. The expertise of our physicians, technologists, scientists and advanced technology leads to more accurate and early reporting. We offer multiple convenient locations, broad health plan access, and low out-of-pocket costs.

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.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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 defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or 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.

Media Contacts:
SimonMed Imaging:
Lauren Strait, (480) 998-2600
lstrait@lavidge.com

iCAD:
Jessica Burns, (623) 203-7270
jburns@icadmed.com

Investor Relations:
LifeSci Advisors, Inc.
Jeremy Feffer, (212) 915-2568
jeremy@lifesciadvisors.com

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