What changed — and whether it can move a shortlist

Snapshot snap_8a8a4c9bb810aee3 · cutoff 2026-08-27T04:05Z. 0 of 13 events in this filter set may change a shortlist.

• 2026-08-15
  ISO 27001, HIPAA, 7+ FDA 510(k)s documented
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.qure.ai/us/regulatory-and-privacy

• 2026-02-26
  openFDA K200921 record
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K200921

• 2026-02-26
  FDA grants six new 510(k) indications for qXR-Detect chest X-ray CADe (26 total cleared indications)
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K200921

• 2026-01-01
  CPT I codes for plaque quantification
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.ama-assn.org/practice-management/cpt

• 2025-11-30
  ~2,000 hospitals / 230M lives covered
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://sacra.com/c/viz-ai/

• 2025-09-22
  Next-gen Plaque Analysis FDA clearance
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://ir.heartflow.com/news-releases/news-release-details/heartflow-announces-fda-510k-clearance-and-launch-next

• 2025-09-22
  FDA 510(k) clearance and launch of next-generation HeartFlow Plaque Analysis platform
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://ir.heartflow.com/news-releases/news-release-details/heartflow-announces-fda-510k-clearance-and-launch-next

• 2025-08-11
  IPO raises $364.2M on Nasdaq (HTFL)
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://ir.heartflow.com/news-releases/news-release-details/heartflow-inc-announces-closing-upsized-initial-public-offering

• 2025-05-20
  IPO targeted within ~2 years
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://m.economictimes.com/tech/artificial-intelligence/healthcare-ai-startup-qure-ai-aiming-for-ipo-in-two-years-ceo-says/articleshow/121286035.cms

• 2024-09-25
  $65M Series D; 3,000+ sites in 90+ countries
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.globenewswire.com/news-release/2024/09/25/2953204/0/en/Global-healthcare-AI-innovator-Qure-ai-completes-65-million-Series-D-funding-round-led-by-Lightspeed-and-360One-Asset.html

• 2024-02-26
  SOC 2 Type II + HIPAA audits completed
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.viz.ai/news/viz-ai-announces-successful-completion-of-soc-2-type-ii-hipaa-audits-for-viz-ai-one-platform

• 2022-10-14
  FDA 510(k) K213857 for FFRct
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213857

• 2018-02-14
  First FDA De Novo for AI stroke triage
  New but not decision-changing · Imaging & Diagnostic AI · Historical
  Provenance

  https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-clinical-decision-support-software-alerting-providers-potential-stroke