WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

adsilico raises 10 million pounds to test implants on virtual patients X9 wins a Breakthrough designation for power-assisted dialysis cannulation Smith+Nephew and J&J ortho merger talks collapse over who would run it Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound Teleflex takes a Breakthrough designation for its resorbable magnesium scaffold in PCI Edwards wins FDA approval for Pascal Precision in tricuspid repair EQT agrees to take Qiagen private for 10.8 billion euros Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans adsilico raises 10 million pounds to test implants on virtual patients X9 wins a Breakthrough designation for power-assisted dialysis cannulation Smith+Nephew and J&J ortho merger talks collapse over who would run it Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound Teleflex takes a Breakthrough designation for its resorbable magnesium scaffold in PCI Edwards wins FDA approval for Pascal Precision in tricuspid repair EQT agrees to take Qiagen private for 10.8 billion euros Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans

510(k)

Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT

MedDevice Startups Staff · 6 days ago · 2 min read · Via Business Wire

Elucid cleared FFR-IQ, software that estimates fractional flow reserve from coronary CT angiography. The 510(k) summary carries K262015 and a September 29, 2026 decision date. The Boston company announced the clearance and commercial availability on October 21.

Elucid calls the method BioIntegrated FFR-CT. Legacy FFR-CT models read lumen geometry. FFR-IQ adds plaque tissue morphology pulled from Elucid's Plaque-IQ analysis software, which is already cleared.

In the ELUCIDATE FFR-CT study, 491 vessels across 347 patients were benchmarked against invasive wire-based FFR. Sensitivity came in at 92.2 percent, specificity at 93.1 percent. Elucid presents the results at TCT in San Diego on November 1. The accuracy ranking in the company's announcement is its own framing, not an FDA finding.

Questions & Answers

What is the K number for Elucid's FFR-IQ clearance?

Elucid's FFR-IQ software cleared under K262015, with a 510(k) decision date of September 29, 2026. Elucid announced the clearance publicly on October 21, 2026.

What does Elucid FFR-IQ do?

FFR-IQ estimates fractional flow reserve noninvasively from coronary CT angiography. Unlike legacy FFR-CT models that read lumen geometry alone, it incorporates plaque tissue morphology from Elucid's Plaque-IQ analysis.

What accuracy did Elucid report for FFR-IQ?

In the ELUCIDATE FFR-CT study, Elucid reported 92.2 percent sensitivity and 93.1 percent specificity against invasive wire-based FFR across 491 vessels in 347 patients. The company plans to present the data at TCT in San Diego on November 1, 2026.

← Back to Newly Cleared