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At the heart of the case is the technology Siemens calls the “Flying Focal Spot,” used in the Mammomat B.brilliant. During an exposure, the otherwise static focal spot moves in the opposite direction inside the X-ray tube, which reduces geometric blur and produces sharper, more detailed images. Hologic claims it created the approach and filed suit in 2024, alleging its competitor had profited from the innovation.<\/p>\n
What the Unified Patent Court ruled<\/h2>\n
Siemens defended its claim to the technology, but to no avail: last week the European court ruled in Hologic’s favor. The judgment orders Siemens Healthineers to remove every Mammomat B.brilliant unit from the market in the three countries and to destroy any unsold systems still held in stock there.<\/p>\n
Beyond the recall, the company must hand over all sales records for the units dating back to August 2018, including detailed data on the profits earned from the affected products. That kind of accounting typically forms the basis for damages calculations in later phases of litigation. Siemens has 60 days to comply or appeal; if it does neither, it faces fines of roughly $11,500 per day of non-compliance.<\/p>\n
The remedies are notable for their breadth. Market removal, destruction of unsold inventory and full disclosure of historical sales going back more than seven years amount to one of the more aggressive injunctions seen in the still-young UPC. They signal that the court is willing to grant pan-European relief with real commercial teeth, not just symbolic findings of infringement.<\/p>\n
How breast tomosynthesis and the flying focal spot work<\/h2>\n
Digital breast tomosynthesis (DBT) is an evolution of conventional mammography. Instead of a single two-dimensional projection, the X-ray tube sweeps through an angular arc and acquires several low-dose projections of the breast. A reconstruction algorithm combines them into thin pseudo-3D slices, letting the radiologist scroll through breast tissue layer by layer.<\/p>\n
This reduces the tissue-overlap problem that hides lesions in 2D mammography, especially in dense breasts, where screening demands complementary strategies<\/a>. The detection gain, however, depends on how sharp each projection is. That is where the flying focal spot comes in: by shifting the X-ray source in sync with the sweep during acquisition, the system compensates for the blur the scan itself introduces, preserving spatial resolution even at short exposure times.<\/p>\n The practical payoff is an image with better-defined microcalcifications and lesion margins \u2014 decisive factors in breast cancer screening. Sharper depiction of clustered microcalcifications, in particular, can be the difference between recalling a patient for biopsy and dismissing a finding as benign. It is no surprise, then, that ownership of the technique is contested so fiercely: it sits at the core of the value proposition of the latest tomosynthesis systems.<\/p>\n It is worth stressing that this is a commercial and legal dispute, not a safety recall. There is no suggestion that the Mammomat B.brilliant produces inferior or unsafe images; the court’s order stems from intellectual-property rights, not clinical performance. For patients already screened on these systems, the ruling changes nothing about the validity of their exams.<\/p>\n For radiology services, the ruling has immediate effect only in the three named countries, but the message is broader. Hospitals and clinics that planned to buy the Mammomat B.brilliant in Germany, France and the Netherlands may face supply delays and uncertainty over support and parts. In markets such as Brazil, the litigation does not halt sales directly, but it tends to shape negotiations, contract warranties and vendors’ portfolio strategies.<\/p>\nClinical and market implications<\/h2>\n