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AiThority Interview With Michael Klein, Chairman and CEO at iCAD

AiThority Interview With Michael Klein, Chairman and CEO of iCAD

Know Me

Hi Michael, please tell us your role and the team you handle at iCAD.

As the CEO of iCAD, a global Medical Technology leader providing innovative Cancer detection and therapy solutions, I have the privilege of leading a very talented team of Technology and Healthcare experts. Through passionate ingenuity, the team at iCAD delivers transformative innovations to precisely and effectively predict, detect, and treat cancer earlier, empowering clinicians to provide quality, cost-effective patient care.

iCAD’s solutions offer benefits to clinicians and patients alike, including:

ProFound AI, the first software for 3D mammography using AI to be FDA-cleared, and

Xoft Axxent Electronic Brachytherapy System, which is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancers (NMSC) and gynecological cancers.

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From your vantage point, what have been the most impressive and important changes in your industry, and how has it changed the way you work?

In recent years, cancer detection and treatment has advanced significantly. At iCAD, we embrace evolution; it inspires us to create world-class, leading-edge technologies that empower clinicians and enhance patient care. Our technology includes transformative innovations that are revolutionizing the future of cancer detection and treatment, and we work passionately to provide precise, powerful solutions that are expertly engineered to optimize operational efficiency, clinician confidence and improve patient outcomes.

For example, in breast cancer detection, digital breast tomosynthesis (DBT), or 3D mammography, is rapidly replacing full-field digital mammography (FFDM), or 2D mammography, in breast cancer screening because of the clinical value it offers in cancer detection, especially in women with dense breasts. Although this advanced technology is becoming the standard of care, as it grows in adoption, it presents significant workload challenges for radiologists, which can overall affect patient care.

ProFound AI offers a transformative solution to this emerging issue. This high-performing concurrent-read, cancer detection, and workflow solution rapidly and accurately analyze each tomosynthesis image, detecting both malignant soft-tissue densities and calcifications with unrivaled accuracy.

Built with the latest Deep Learning technology, ProFound AI has been trained to detect malignant lesions in 3D mammography images. It is clinically proven to improve cancer detection rates by 8 percent, reduce unnecessary patient recall rates by 7.2 percent, and slash reading time for radiologists by 52.7 percent and up to 57.4 percent for dense breast 3D image analysis.

Regarding cancer treatment, in recent years we have seen a shift towards more personalized care and abbreviated cancer therapy courses. Our flagship product for cancer therapy, the Xoft System, is an innovative radiation oncology treatment solution that offers significant cost, mobility, and treatment time advantages over competitors or the standard of care.

The Xoft System uses a miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site while minimizing risk of damage to healthy tissue in nearby areas of the body.

For the treatment of early-stage breast cancer, intraoperative radiation therapy (IORT) with the Xoft System allows appropriately selected patients to potentially replace four to six weeks of postoperative external beam radiation therapy (EBRT) with a single-fraction of radiation that can last as little as ten minutes.

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Patient care is often seen as the pinnacle of any form of Customer Experience. What unique benchmarks have you set for iCAD?

At iCAD, patient care is at the center of everything we do. We work passionately to provide precise, powerful healthcare solutions expertly engineered to optimize operational efficiency, clinician confidence, and patient outcomes. As a leader in medical technology, our key benchmarks are defined by clinical research.

A growing body of evidence continues to support the Xoft System across multiple cancer types, including early-stage breast cancer, gynecological cancers, nonmelanoma skin cancers, and recently, brain tumors. iCAD recently announced the first metastatic brain tumor was treated in the U.S. with IORT using the Xoft System at the James Graham Brown Cancer Center at the University of Louisville.

The Xoft System is also currently being studied for the treatment of other types of brain tumors in leading institutions worldwide, including the European Medical Center, one of the largest private medical clinics in Russia, and an international leader in comprehensive care and oncology. The Company continues to work with key neurosurgeons to enroll patients in a multi-institutional study on Xoft IORT for the treatment of recurrent glioblastoma (GBM).

Our technology is world-class, and it is our mission to bring leading-edge solutions to markets that are poised to enhance patient care and improve lives in the years ahead.

You have partnered with TME Breast Care Network to discuss enhancing clinical care during COVID-19. What are the biggest challenges that you are facing today?

Upon the outset of the pandemic, a number of organizations, such as the American Cancer Society, the American College of Radiology, and the Susan G. Komen Foundation, issued guidance that women should defer screening this year if they are at lower risk of developing breast cancer. However, as important as it is for us all to work together to “flatten the curve,” some women may still be at risk of developing breast cancer.

During this time, it is crucial for Radiologists to be able to determine which women should not defer screening. Additionally, once this pandemic passes, radiologists will be faced with a significant backlog of patients who will need to be screened. Improving accuracy and efficiency for breast cancer screening will then be more essential than ever.

iCAD’s technologies offer unique value propositions in light of this pandemic. ProFound AI offers a leading-edge solution that provides radiologists with the ability to review prior year mammograms and prioritize which patients should not delay breast cancer screening based on the technology’s unique Case Score, which represents a relative level of suspicion for the case containing potentially cancerous findings that may require further workup. It is also clinically proven to reduce the reading time for radiologists, which can help radiologists more effectively manage the backlog they may face.

Additionally, IORT with the Xoft System offers a single-fraction therapy option that allows patients who are candidates to replace weeks of daily radiation with one treatment, delivered at the time of surgery. This treatment option could also significantly reduce the healthcare system resources needed and reduce patients’ risk of COVID-19 exposure.

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How do you help physicians, radiologists, and others manage the frenetic number of cases lining outside clinics to get their routine tests done?

ProFound AI offers crucial information for radiologists, such as Certainty of Finding lesion and Case Scores, which can help clinicians assess which patients would benefit more from screening.

Improving mammography accuracy and efficiency helps doctors to focus on the patients who really need it while keeping more healthy patients safe at home.

New forms of Cyber threats are emerging. Healthcare and Life Science institutions are the primary targets? How do you analyze these threats at iCAD

As new forms of cyber threats emerge, iCAD is committed to investing in cutting-edge technology to safeguard the organization and our customers from potentially harmful cyber activity. iCAD’s products are delivered on a Microsoft platform that is installed behind the customer’s firewall to leverage cyber threat technologies deployed by our customers.

Furthermore, the platform is flexible in allowing our customers to install the virus protection software of their choice. Additionally, all of our products are fully tested for vulnerabilities prior to release.

Our IT team also works diligently to safeguard employee communication and reduce risk with targeted threat protection, data leak prevention, and enforced email security controls.

Post-COVID pandemic, how would you want to see radiology practices and imaging centers evolve to meet critical care requirements?

COVID-19 has introduced unprecedented challenges to clinicians and the healthcare system, and it will be essential for radiology practices and imaging centers to evolve once this passes in order to deliver quality patient care.

AI has been emerging as a critical tool across many facets of healthcare in recent years. When it comes to breast cancer imaging specifically, AI solutions such as ProFound AI, offer a transformative solution that is positioned to make a significant impact on patient care post-COVID and for years to come.

Read More: AiThority Interview with Chris Hazelton, Director of Security Solutions at Lookout

Tag the one person in the industry whose answers to these questions you would love to read:

iCAD is grateful to work with some of the most forward-thinking providers in the breast cancer screening and radiation therapy industry. Based on his commentary on our recent roundtable, we would be interested to hear responses from Randy Hicks, Co-owner and CEO at Regional Medical Imaging.

Thank you, Michael! That was fun and hope to see you back on AiThority soon.

Michael Klein serves as the Chairman and CEO for iCAD Medical, a clinical Artificial Intelligence company focused on the detection of breast cancer and other proliferative diseases. iCAD’s, therapy subsidiary, Xoft Inc. uses novel electronic brachytherapy for the treatment of breast and gynecological cancers as well as brain, rectal, and prostate cancers.

Between December 2014 and October 2018, when he assumed the above position, Klein served as Chief Executive Officer at Inflection Point Consulting, an executive coaching and consulting firm with a focus on medical technology, biopharma, and healthcare services. During this same time period, Klein served as a Adjunct Professor at the Leavey School of Business at Santa Clara University.


iCAD is a leading global provider of advanced image analysis, workflow solutions, and radiation therapies for the early detection and treatment of cancer. iCAD offers advanced breast cancer detection solutions built on artificial intelligence, that enable radiologists to find cancers earlier while improving reading workflow.

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