HeartFocus (V.1.1.1)

Evidence summary

The initial Clarius/v1.1.1 evidence supports trained-user image acquisition with expert interpretation. Current Butterfly family features and commercial terms cannot be used as original-study results.

FDA source Exact FDA submission Checked 2026-09-05

• Source

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify security and privacy controls: FDA-local data flow is documented, but FAQ/pricing security language does not supply a dated scoped attestation or a complete installed security-control assessment.
• Verify reimbursement and coding relevance: No applicable CMS policy content reviewed. Acquisition software pricing does not establish reimbursement for the software or the underlying echo service.
• Verify local validation and lifecycle monitoring: Editorial acceptance questions concern installed probe/OS/model compatibility, per-view failures, rescue scanning, saved-clip review and DICOM transfer; no vendor monitoring service is verified.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Stored DESKi-sponsored PROSPECTIVE EVALUATION OF HEARTFOCUS metadata screened. Live registry page exposed only an application shell, so trial details and exact release linkage were not established; no registry result promoted. Clinical-study abstraction is sourced to the FDA summary only. Stored PubMed array empty. The current discovery snapshot contains 0 PubMed and 1 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, fda decision summary, acr ai central product, vendor product page, vendor pricing, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall

• FDA 510(k) K242807: HeartFocus v1.1.1 U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• HeartFocus (V.1.1.1) model card (K242807) 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
• HeartFocus official FAQ: current product family DESKi / HeartFocus · 2026-09-05
• HeartFocus current family pricing DESKi / HeartFocus · 2026-09-05