FDA approves a computer second read of mammograms
On 26 June 1998 the FDA approved R2 Technology's ImageChecker M1000, a system that marks suspicious regions on a screening mammogram for the radiologist to review after the initial reading.
Why it matters
A program that looks for cancer on an image could be sold to clinics, but only as a second read after a person. The FDA made a further study a condition of approval: how the system would change the number of false-positive work-ups.
Approval under PMA P970058; the advisory panel met on 11 May 1998. In the applicant's prospective study 14 radiologists at 5 institutions read 23,682 cases before installation and 14,817 after; the mean work-up rate was 8.3% and 7.6%, and the FDA recorded no significant increase. In a retrospective study the system marked 17 of 21 malignant microcalcifications on prior films. The FDA documents do not call the approval the first, and the record does not claim it.