Delphinus Medical Technologies

Delphinus Medical Technologies specializes in breast ultrasound imaging systems. Their primary focus is on automated whole-breast ultrasound devices, such as the SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly. These systems are designed to provide detailed imaging of breast tissue, supporting diagnostic and screening workflows.

Delphinus Medical Technologies is based in the United States. The company operates within the US regulatory framework, which governs the development, approval, and distribution of its medical devices.

Delphinus Medical Technologies’ devices fall under FDA Class III classification. This classification applies to high-risk medical devices that require Premarket Approval (PMA) due to their potential impact on patient safety and health outcomes. Class III designation reflects the rigorous regulatory scrutiny these devices undergo.

Delphinus Medical Technologies’ devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US regulatory requirements. Additionally, their Premarket Approval (PMA)-cleared devices are documented in the FDA’s PMA registry, which tracks high-risk medical devices authorized for market distribution.

Delphinus Medical Technologies’ devices are classified as Class III under FDA regulations, which applies to devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Automated whole-breast ultrasound systems fall into this category because they provide critical diagnostic information for breast cancer screening and diagnosis, necessitating PMA to ensure safety, effectiveness, and proper performance before market authorization.