đź“Š Evidence-Based Reference
Softvue Automated Whole Breast Ultrasound System with Sequr Breast Interface
Delphinus Medical Technologies
Summary: The SoftVue Automated Whole Breast Ultrasound System by Delphinus Medical Technologies is designed for breast tissue imaging. It is primarily used for characterizing breast tissues and masses. Key evidence includes a multicenter study evaluating whole breast stiffness imaging.
FDA Clearance Information
Pathway ?
PMA
Number ?
P200040 ↗
Decision Date ?
April 11, 2024
Product Code ?
PAA
Device Class ?
Class 3
Evidence ?
0 studies
The SoftVue Automated Whole Breast Ultrasound System received FDA clearance through the PMA pathway on April 11, 2024. It is manufactured by Delphinus Medical Technologies and is classified as a Class 3 device.
What It Is
The SoftVue Automated Whole Breast Ultrasound System is a diagnostic imaging device that uses ultrasound tomography to assess breast tissue stiffness. It is intended for use in the characterization of breast tissues and masses, providing volumetric imaging data.
FDA-Cleared Indications
- FDA approval covers a manufacturing-site change for the SoftVue Automated Whole Breast Ultrasound System to Delphinus Medical Technologies, Inc., 45525 Grand River Ave, Suite 100, Novi, MI 48374-1308.
Clinical Applications
- Volumetric ultrasound imaging of breast tissue
- Characterization of breast tissue
- Characterization of breast masses
- Evaluation of palpable breast lesions
- Evaluation of mammographically or sonographically visible breast lesions
Evidence Summary
The available literature includes six studies, with one notable multicenter study involving 206 women and 298 breast masses. The studies span various years, with the most recent published in 2024, focusing on the device's imaging capabilities.
Reported Outcomes
Published studies report that the SoftVue system effectively maps differences in breast tissue stiffness, aiding in the characterization of masses. The multicenter study identified 78 cancers, 105 fibroadenomas, 91 cysts, and 24 other benign masses, demonstrating the device's diagnostic utility.
Safety Profile
Reported complications include no significant adverse events directly linked to the use of the SoftVue system. The studies reviewed did not highlight any specific safety concerns, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by the lack of long-term outcome data and the need for further research to validate findings across diverse populations. Some studies lack detailed safety and efficacy outcomes, necessitating additional investigation.
Practical Considerations
- This is an ultrasound-based breast imaging system, not an MRI device, and it does not use ionizing radiation.
- The patient’s breast is positioned in the system’s dedicated breast interface during image acquisition.
- The system is intended for breast imaging and should not be treated as a general-purpose ultrasound system.
- Findings may require correlation with mammography, diagnostic ultrasound, MRI, clinical examination, or tissue sampling.
- Use should follow the current manufacturer instructions, FDA labeling, and facility protocols.
Frequently Asked Questions
What are the clinical indications for SoftVue Automated Whole Breast Ultrasound System?
The device is indicated for the characterization of breast tissues and masses, particularly in patients with palpable or imaging-visible lesions.
What outcomes have been reported in clinical studies?
Studies report effective differentiation of breast tissue stiffness, identifying various masses including cancers and benign lesions.
What complications have been reported?
Reported complications include no significant adverse events, with studies indicating a favorable safety profile.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.