Vara wins world’s first CE mark for AI that clears mammograms alone
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 same day. The mark is a Class IIb CE certification under the EU Medical Device Regulation, covering what Vara calls autonomous triage in organised breast cancer screening.
Screening programmes across Europe read every mammogram twice. Vara puts the share of those images that turn out normal at around 97%. Meanwhile the radiologist workforce is shrinking and screening ages keep widening. That is the pressure the certification addresses.
What the certification permits
Under autonomous triage, the AI reports the examinations it classifies as clearly normal. No radiologist reads them. Every other examination still goes to...
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