News | Computer-Aided Detection Software | June 01, 2018

FDA Proposes to Reclassify Some Types of Radiology Image Software Analyzers

Proposed order would reduce regulatory approval burden for various computer-aided detection devices

FDA Issues Proposed Order to Reclassify Certain Radiological Medical Image Analyzers

June 1, 2018 — The U.S. Food and Drug Administration (FDA) is issuing a proposed order to reclassify certain radiological medical image analyzers, or computer-aided detection (CAD) devices, from class III to class II devices. This includes CAD devices for mammography breast cancer, ultrasound breast lesions and radiograph lung nodules.

If finalized, this proposed order will reclassify CAD devices for certain radiological applications from Class III devices requiring premarket approval, to Class II devices, requiring a less burdensome premarket notification (510(k)) with special controls. This will reduce the regulatory burden on the medical device industry, streamline review for these types of devices, and provide more timely access to these devices for patients.

The agency is proposing special controls that, in addition to general controls, will provide a reasonable assurance of safety and effectiveness.

This proposed order is part of the Center for Devices and Radiological Health’s goal to strike the right balance between premarket and postmarket data collection. This proposed order also promotes innovation in diagnostic imaging, according to the FDA, through a more consistent and streamlined approach to review many types of radiological computer aided-detection, diagnosis and triage software under the 510(k) pathway. Streamlined premarket review will provide for more timely access to these types of devices for patients, while still maintaining the highest standards of safety and effectiveness.

The agency said it welcomes comments regarding this proposed order. The comment period will be open for 60 days.

Questions about this proposed order can be directed to CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], or via phone at 1-800-638-2041, or (301) 796-7100.

For more information: www.fda.gov

Related Content

MaxQ AI Launches Accipio Ax Slice-Level Intracranial Hemorrhage Detection
Technology | Computer-Aided Detection Software | May 21, 2019
Medical diagnostic artificial intelligence (AI) company MaxQ AI announced that Accipio Ax will begin shipping in August...
Life Image and Bialogics Analytics Partner to Deliver Imaging Business Intelligence
News | Analytics Software | May 21, 2019
Life Image and business intelligence analytics provider Bialogics Analytics have formed a strategic partnership that...
AI Detects Unsuspected Lung Cancer in Radiology Reports, Augments Clinical Follow-up
News | Artificial Intelligence | May 20, 2019
Digital Reasoning announced results from its automated radiology report analytics research. In a series of experiments...
Tru-Vu Monitors Releases New Medical-Grade Touch Screen Display
Technology | Flat Panel Displays | May 17, 2019
Tru-Vu Monitors released the new MMZBTP-21.5G-X 21.5” medical-grade touch screen monitor. It is certified to both UL...
3 Recommendations to Better Understand HIPAA Compliance
Feature | Information Technology | May 17, 2019 | Carol Amick
According to the U.S.
The webinar "Realizing the Value of Enterprise Imaging: 5 Key Strategies for Success" will outline how to improve patient care, lower costs and reduce IT complexity through a well-designed enterprise Imaging strategy.  Change Healthcare
Webinar | Enterprise Imaging | May 16, 2019
The webinar "Realizing the Value of Enterprise Imaging: 5 Key Strategies for Success" will outline how to improve pat
Videos | Advanced Visualization | May 16, 2019
This is an example of how virtual reality is being used in neuro-radiology to better evaluate patients using advanced
Managing Architectural Distortion on Mammography Based on MR Enhancement
News | Mammography | May 15, 2019
High negative predictive values (NPV) in mammography architectural distortion (AD) without ultrasonographic (US)...
FDA Clears Aidoc's AI Solution for Flagging Pulmonary Embolism
Technology | Artificial Intelligence | May 15, 2019
Artificial intelligence (AI) solutions provider Aidoc has been granted U.S. Food and Drug Administration (FDA)...
Icon Launches New Clinical Trial Patient Engagement Platform
Technology | Patient Engagement | May 14, 2019
Icon plc announced the release of its web-based clinical trial patient engagement platform, to provide patients with...