Cleerly vs ScreenPoint Transpara

ScreenPoint states that Transpara was the tool in MASAI, a randomized screening trial of more than 105,000 women run by Lund University. The vendor reports a 12% lower interval cancer rate and sensitivity of 80.5% against 73.8% at 98.5% specificity. MASAI ran in Sweden's double-reading screening, so carry-over to US sites that read once is open. Transpara has eight FDA 510(k)s, the latest K260898 in August 2026, works on 2D FFDM and 3D DBT mammograms, and has a separate Density clearance from December 2023. The vendor calls it a second pair of eyes and vendor agnostic.

Transpara serves breast imaging centers and screening programs with FFDM or DBT units, and Cleerly serves coronary CTA programs, so the two address separate exams. For a coronary CTA program, Cleerly's draw is CPT 75577, in effect since January 2026, which gives plaque analysis a Category I billing code.