icad (ICAD) FDA Events

icad's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by icad (ICAD). Over the past two years, icad has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as RPS, RPS, and RPS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

RPS 1002 FDA Regulatory Events

RPS 1002 is a drug developed by icad for the following indication: AI in Breast Imaging. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Oral presentation - February 19,2025

• Drug: RPS 1002
• Announced Date: February 19, 2025
• Estimated Event Date Range: February 27, 2025 - February 27, 2025
• Target Action Date: February 27, 2025
• Indication: AI in Breast Imaging

Announcement

iCAD, Inc. announced the Oral Presentations of RPS 1002 – Exploring the Role of AI in Breast Imaging

AI Summary

iCAD, Inc. announced its oral presentations at the European Congress of Radiology (ECR) 2025. One key session, “RPS 1002 – Exploring the Role of AI in Breast Imaging,” is scheduled for February 27. In this presentation, Mikael Eriksson from Stockholm will discuss a 10-year image-derived AI risk model meant to help in the primary prevention of breast cancer. The session highlights how artificial intelligence can be used to improve personalized risk assessments, early detection, and overall breast imaging workflows. This effort is part of iCAD’s ongoing commitment to advancing AI-powered solutions in breast health. The company’s innovations, including a secure and scalable platform called ProFound Cloud, are aimed at empowering healthcare providers to achieve better outcomes through advanced imaging and risk evaluation tools.

RPS 2202 FDA Regulatory Events

RPS 2202 is a drug developed by icad for the following indication: Personalized Risk Prediction of Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Oral presentation - February 19,2025

• Drug: RPS 2202
• Announced Date: February 19, 2025
• Estimated Event Date Range: February 27, 2025 - February 27, 2025
• Target Action Date: February 27, 2025
• Indication: Personalized Risk Prediction of Breast Cancer

Announcement

iCAD, Inc. announced the Oral Presentations of RPS 2202 – Personalized Risk Prediction of Breast Cancer

AI Summary

iCAD, Inc. announced an important session on personalized risk prediction for breast cancer at the upcoming European Congress of Radiology 2025. The Oral Presentation titled “RPS 2202 – Personalized Risk Prediction of Breast Cancer” will focus on short-term risk prediction using AI tools. Presenters, including Emily Conant, Chirag Parghi, Per Hall, and Mikael Eriksson, will compare risk tools used with digital mammography and digital breast tomosynthesis in U.S. screening populations. Another related study will discuss adding AI case scoring to optimize reading workflow and workload. This research highlights iCAD’s commitment to improving breast cancer screening by using advanced AI to accurately predict risk and support early detection. The findings aim to help clinicians choose the best digital tools, contributing to better patient care and more efficient screening programs.

RPS 705 FDA Regulatory Events

RPS 705 is a drug developed by icad for the following indication: Artificial Intelligence in Breast Imaging. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Oral presentation - February 19,2025

• Drug: RPS 705
• Announced Date: February 19, 2025
• Estimated Event Date Range: February 27, 2025 - February 27, 2025
• Target Action Date: February 27, 2025
• Indication: Artificial Intelligence in Breast Imaging

Announcement

iCAD, Inc. announced the Oral Presentations of RPS 705 – Artificial Intelligence in Breast Imaging

AI Summary

iCAD, Inc. announced that its oral presentation, RPS 705 – Artificial Intelligence in Breast Imaging, has been accepted for the prestigious European Congress of Radiology (ECR) 2025 in Vienna, Austria. The presentation, scheduled for February 27 from 08:00 to 09:30 CET, will focus on the optimal utilization of an AI diagnostic software within a mammography screening program in Switzerland. Marcel Blum from St. Gallen will present the research, which highlights how artificial intelligence can enhance breast imaging, leading to improved detection and more efficient screening workflows. This study is part of a broader effort by iCAD to leverage AI technology for more personalized risk evaluation and earlier identification of breast cancer, ultimately supporting better outcomes in patient care. iCAD continues to demonstrate its commitment to advancing breast imaging through innovative AI-powered solutions.

icad FDA Events - Frequently Asked Questions

Has icad received FDA approval?

In the past two years, icad (ICAD) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

What drugs has icad submitted to the FDA?

In the past two years, icad (ICAD) has reported FDA regulatory activity for the following drugs: RPS 1002, RPS 2202 and RPS 705.

What is the most recent FDA event for icad?

The most recent FDA-related event for icad occurred on February 19, 2025, involving RPS 1002. The update was categorized as "Oral presentation," with the company reporting: "iCAD, Inc. announced the Oral Presentations of RPS 1002 – Exploring the Role of AI in Breast Imaging"

What conditions do icad's current drugs treat?

Current therapies from icad in review with the FDA target conditions such as:

• AI in Breast Imaging - RPS 1002
• Personalized Risk Prediction of Breast Cancer - RPS 2202
• Artificial Intelligence in Breast Imaging - RPS 705