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U.S. FDA clears Transpara 1.6.0 manufactured by ScreenPoint Medical, the first breast AI solution for both 2D and 3D mammography in the USA.
In order to obtain FDA clearance, the company performed a clinical reader study which demonstrated that accuracy of radiologists significantly improved when reading 3D mammograms with support from Transpara. In addition, 3D reading time was significantly reduced to about 35 seconds per exam, bringing it close to 2D reading efficiency.
"We are delighted that the U.S. FDA has cleared Transpara 1.6.0 to be marketed in the USA. This is a major breakthrough from ScreenPoint Medical and it means that our new and existing US customers now have access to the power of Transpara 3D for the first time," says CEO Nico Karssemeijer. "Multiple independent peer reviewed publications have already demonstrated that Transpara significantly improves accuracy in 2D mammography, now the same applies for 3D."
"We also understand that reading 3D mammography presents radiologists with huge workload challenges. With feedback from the field, we redesigned the Transpara 1.6.0 interface and utilised our patented co-registration slice technology to optimise reading workflow with advanced navigation support to significantly reduce reading times."
Pieter Kroese, COO at ScreenPoint Medical adds, "Transpara 1.6.0 heralds a new era in breast AI in terms of 2D and 3D workflow. Transpara is the leading evidence-based breast AI solution for mammography, with clinical installations in over 15 countries and over 500,000 mammograms processed so far by our clinical users. This is a significant achievement and demonstrates the strong trust that we share with our clinical partners and that Transpara breast AI is making a difference for women and the detection, diagnosis and treatment of breast cancer."
Transpara 1.6.0 is marketed in North America by ScreenPoint Medical Inc, Siemens Healthineers USA and Volpara Solutions.
About ScreenPoint Medical BV.
ScreenPoint Medical is the leading developer of AI driven image analysis technology which enables the automated reading of mammograms and digital breast tomosynthesis examinations. With proven accuracy at least matching that of experienced radiologists, ScreenPoint's Transpara™ system is the most advanced available, exploiting Big Data, Deep Learning and the latest advances in Artificial Intelligence. The system can identify high risk breast lesions quickly, enabling earlier detection, earlier treatment and a greater chance of survival.
ScreenPoint Medical was founded in 2014 by Professor Nico Karssemeijer and Professor Sir Michael Brady, two internationally respected experts in breast imaging, machine learning and computer aided detection.
The company's Head Office is in Nijmegen, The Netherlands.
For more information, please email firstname.lastname@example.org
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