This section highlights FDA-related milestones and regulatory updates for drugs developed by RadNet (RDNT).
Over the past two years, RadNet has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Saige and SmartMammo. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Saige DX - FDA Regulatory Timeline and Events
Saige DX is a drug developed by RadNet for the following indication: In patients with unilateral breasts and with breast implants.
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.
- Drug:
- Saige DX
- Announced Date:
- November 29, 2024
- Indication:
- In patients with unilateral breasts and with breast implants.
Announcement
DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc. and a global leader in AI-powered health informatics, has received expanded FDA 510(k) clearance for its innovative mammography software.
AI Summary
DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc. and a global leader in AI-powered health informatics, has earned expanded FDA 510(k) clearance for its innovative mammography software. The clearance now permits its SmartMammo Dx algorithm to work with GE HealthCare’s Senographe Pristina™ systems. This integration allows radiologists to benefit from enhanced cancer detection, as the AI-driven software improves diagnostic accuracy by identifying suspicious lesions and calcifications in digital breast tomosynthesis (DBT) mammograms.
This expanded clearance broadens the software’s compatibility across different mammography systems, aiming to provide higher quality breast cancer screening to a larger patient base. DeepHealth’s advanced imaging solutions continue to redefine radiology workflows by improving speed, clinical accuracy, and operational efficiency. The collaboration with GE HealthCare is a significant step in the company’s commitment to enhancing patient care and advancing breast imaging technology.
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SmartMammo Dx - FDA Regulatory Timeline and Events
SmartMammo Dx is a drug developed by RadNet for the following indication: In patients with unilateral breasts and with breast implants.
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.
- Drug:
- SmartMammo Dx
- Announced Date:
- November 29, 2024
- Indication:
- In patients with unilateral breasts and with breast implants.
Announcement
DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc has received expanded FDA 510(k) clearance for its innovative mammography software. SmartMammo Dx, the AI algorithm within SmartMammo1, is now FDA-cleared to be compatible with GE HealthCare's Senographe Pristina™ mammography systems.
AI Summary
DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc., has received expanded FDA 510(k) clearance for its innovative mammography software. The clearance now covers SmartMammo Dx, the AI algorithm within its SmartMammo1 system, and confirms that the software is compatible with GE HealthCare's Senographe Pristina™ mammography systems. This critical update demonstrates that SmartMammo Dx meets strict FDA safety and performance criteria, ensuring it can reliably support breast cancer screening workflows.
The approval is an important milestone for DeepHealth and the radiology community, as it offers healthcare providers a powerful tool to enhance the accuracy of mammography diagnoses. By integrating AI into traditional imaging systems, the solution aims to improve diagnostic consistency and ultimately streamline patient care while reducing false recalls and unnecessary examinations.
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