AI Company Scores World’s 1st Approval for Breast Triage Tool that Skips Radiologist Review
The certification follows a Nature Medicine study that found the tool increased breast cancer detection by nearly 20% across nearly 462,000 women.
Vara announced the achievement on Sept. 3, with the Berlin, Germany-based technology firm earning CE Certification under the EU's Medical Device Regulation.
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Vara wins world's first CE mark for autonomous breast AI
A Berlin company has won the world’s first regulatory clearance for AI that closes a breast screening case. No radiologist looks at it. Vara, which trades as MX Healthcare GmbH, announced the certification on Wednesday in a statement issued through Business Wire. Chief executive Jonas Muff set out the reasoning in a longer post the […] This story continues at The Next Web
Vara obtained a Class IIb CE certification so that her AI autonomously discards clearly normal mammograms in organized screening programs. Advances reduce human reading from part of the studies, although the company's main published evidence assessed a different use and not autonomous triage.
Vara nets first CE mark for autonomous AI breast cancer screening tool
Vara has secured a European CE mark for an autonomous, artificial intelligence (AI)-powered breast cancer screening triage tool – marking the first time a device of this nature has secured an authorisation globally. Designated as a Class IIb medical device under the EU's medical device regulation…
Vara Receives World-First CE Certification for Autonomous AI in Breast Cancer Screening – Novumpr
BERLIN, Germany–(BUSINESS WIRE)– Vara has received CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening – the first breast AI certified anywhere to report screening examinations as normal without radiologist review. In autonomous triage, examinations the system classifies as clearly normal can be reported by AI […]
BERLIN, Germany-- (BUSINESS WIRE) --Vara has obtained CE certification under the European Medical Device Regulation (Class IIb) for autonomous triage as part of organized breast cancer screening. It is the first certified AI dedicated to breast cancer screening in the world capable of declaring screening exams as normal without examination by a radiologist. As part of autonomous triage, exams that the system classifies as clearly normal may be
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