Folliscan

Evidence summary

The FDA summary describes a held-out test set of 138 scans from 64 patients at five clinics, including 45 US scans, with expert-reviewed reference contours and patient-separated development/test data.

FDA source Exact FDA submission Checked 2026-09-05

Development involved 2132 patients at seven centers and 6404 DICOM datasets; those are not the test denominator. No IVF outcome benefit is inferred.

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-06

Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

• Verify security and privacy controls: Family FAQ makes hosting/encryption statements, but scoped dated security evidence and exact-US-configuration data-processing terms were not established.
• Verify training: Exact connector/operator training curriculum, competency assessment and costs require confirmation.
• Verify pricing and total cost: Reviewed product page offers contact/demo access, not a verified license, connector, edge-device or implementation price.
• Verify reimbursement and coding relevance: No applicable IVF/ultrasound payer policy reviewed; no coverage or separate-payment conclusion is made.
• Verify local validation and lifecycle monitoring: Contracted post-installation quality monitoring and incident-handling responsibilities were not established.
• Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

Stored literature-index and trial-registry candidate arrays were empty and screened. This does not establish absence of literature; current vendor page links newer papers/posters that were not fully reviewed or promoted here. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

• Folliscan: K252332 clearance and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Folliscan model card (K252332) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Folliscan product and integration FAQ MIM Fertility · 2026-09-06