FDA applicant

Exact Sciences Corporation

Madision3 decisions2014–20242 recalls

FDA records 3 decisions for Exact Sciences Corporation (Madision) from 2014 to 2024: 3 original PMA approvals. Most are in product codes PHP (System, Colorectal Neoplasia, Dna Methylation…) and PQP (Next Generation Sequencing Oncology Panel…). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Exact Sciences Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2023

2014high 1 (2017) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Exact Sciences Corporation by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Exact”

FDA records each applicant name separately; these may or may not be the same firm.

Exact Medical Manufacturing, Inc. 9 Exact Imaging, Inc. 4 Exact Supplies, Ltd. 1 Exact Science, Inc. 1

Exact Sciences Corporation

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Exact”