Siemens Healthcare Mammomat Inspire With Breast Tomosynthesis PMA FDA

July 2, 2014 — Siemens Healthcare recently submitted its premarket approval application (PMA) for the Mammomat Inspiration with Breast Tomosynthesis option to the U.S. Food and Drug Administration (FDA).

In this PMA submission, Siemens Healthcare has provided the FDA with clinical study results and manufacturing information. The Siemens Breast Tomosynthesis option has been designed as an add-on option for the Mammomat Inspiration digital mammography system. In tomosynthesis mode, the Mammomat Inspiration acquires 25 projection views over an angular range of 50 degrees to produce 3-D digital breast tomosynthesis (DBT) images. These images are intended to be suitable for the screening and diagnosis of breast cancer.

The Siemens Breast Tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia and South America. In the United States, the FDA classifies breast tomosynthesis as Class III, meaning that data from a clinical trial is required to measure safety and effectiveness. Class III devices require a PMA submission to the FDA for approval.

For more information: www.siemens.com/healthcare


Related Content

News | Breast Imaging

July 8, 2025 — QT Imaging Holdings, has appointed Elaine Iuanow, MD, as chief medical officer (CMO) and Kim Du as senior ...

Time July 09, 2025
arrow
News | Breast Imaging

July 7, 2025 — SimonMed Imaging, one of the largest outpatient medical imaging providers in the United States, has ...

Time July 08, 2025
arrow
News | Breast Imaging

June 25, 2025 — QT Imaging Holdings, Inc., a medical device company engaged in research, development, and ...

Time June 25, 2025
arrow
News | Mammography

April 29, 2025 — iCAD, a global provider of clinically proven AI-powered cancer detection solutions, has announced a ...

Time April 29, 2025
arrow
News | Mammography

April 24, 2025 — GE HealthCare will feature its latest advancements in diagnostic accuracy and patient-centered breast ...

Time April 24, 2025
arrow
News | Artificial Intelligence

March 10, 2025 — Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, has published a ...

Time March 10, 2025
arrow
News | Artificial Intelligence

Feb. 19, 2025 — SimonMed Imaging and HeartLung Technologies have signed a strategic partnership to offer HeartLung's AI ...

Time March 04, 2025
arrow
News | Ultrasound Imaging

Jan. 28, 2025 — GE HealthCare recently announced it has received 510(k) clearance from the United States Food and Drug ...

Time January 29, 2025
arrow
News | Breast Imaging

Jan. 8, 2025 — ScreenPoint Medical has acquiredf Biomediq A/S, a research-based company focused on the research ...

Time January 10, 2025
arrow
News | Breast Imaging

Dec.11, 2024 — iCAD, Inc., a provider of clinically proven AI-powered cancer detection solutions, recently announced ...

Time December 18, 2024
arrow
Subscribe Now