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Siemens Healthineers nabs FDA premarket approval for 3D imaging for mammo system

por Lauren Dubinsky, Senior Reporter | September 30, 2024
Women's Health
Mammomat B.brilliant mammography system
Siemens Healthineers announced today that it received FDA premarket approval for 3D breast imaging technology for its Mammomat B.brilliant mammography system.

“From my perspective, it’s an enormous step for us as an organization to be able to bring this innovation out to the market,” Niral Patel, head of X-ray products for Siemens Healthineers North America, told HCB News. “It’s going to help a lot of people get diagnosed with cancer earlier and with more accuracy because of the innovations that we put into the system.”

The company’s Women’s Health business partnered with its CT product line to create a new CT tube for this system. It leverages flying focal spot technology, meaning the system is able to obtain very crisp images, according to Christie Devine, Women’s Health product manager for Siemens Healthineers North America.

“If you’ve ever been in a car or on a train and you’ve been trying to take a picture of something out in the distance and it’s all fuzzy — that’s essentially what all 3D vendors have had to struggle with,” she said. “They’ve tried to overcome this motion of the tube movement while taking pictures.”

The Mammomat B.brilliant features 50-degree wide-angle technology, which addresses the issue with overlapping breast tissue that’s often encountered with 2D imaging. This new technology separates the overlapping layers to uncover hidden lesions.

The company has expanded on this wide-angle technology with the new PlatinumTomo 3D technology, which can acquire a 50-degree angle in under five seconds. It lessens the blur that is common with 3D imaging.

“We want to make it so that when women do get their imaging, it’s a more accurate exam because they can rely on that wide angle to help the radiologists with better image interpretation,” said Devine.

The system’s new UltraHD image reconstruction technology can reduce metal artifacts, allowing for better visualization of calcifications. Devine explained that this technology is important for cancer detection and has great mass conspicuity from depth resolution or tissue separation.

The system addresses patient comfort with several features including rounded breast compression paddles and optimal compression technology. The latter can automatically sense the optimal compression for each patient so that they’re not over-compressing, but are still getting great images for the radiologist.

“We want to make sure that every time an image is taken, that the compression used to hold the breast in place is optimal for the radiologist to review that image, but we also don’t want to overdo it,” said Devine. “We don’t want to put so much compression on a patient that they don’t want to come back next year.”

Siemens Healthineers also had the radiologic technologist in mind when developing the system. The ComfortMove ergonomic feature allows them to move the tube head independently of the image receptor so they can easily access the patient during positioning.

The system incorporates what Devine refers to as the “one-click philosophy,” which can help to reduce repetitive strain injury. The machine is programmed to know what the technologist’s routine is when logging in, so it only takes one click for it to know the technologist’s next step.

“I’m a former mammo technologist and I’ve experienced it all and my colleagues still experience this stuff today,” said Devine. “Whatever we can do to help them and create a happier, healthier workforce — that’s what we want.”

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