FDA clears Elucid's plaque-informed FFR-CT software, FFR-IQ
Elucid received FDA 510(k) clearance for FFR-IQ, software that estimates fractional flow reserve from coronary CT angiography and uses plaque composition data from its PlaqueIQ product. The company says the clearance rests on the ELUCIDATE trial (491 vessels, 347 patients), where it reported 92.2% sensitivity and 93.1% specificity against invasive FFR. Elucid plans to combine FFR-IQ and PlaqueIQ in a single platform. Trade press reports it as the third commercially available FFR-CT product in the US, after HeartFlow and Keya Medical.
Why it's notable: A new vendor in non-invasive FFR-CT adds competition in a market long dominated by HeartFlow, and may offer cardiology and imaging programs another way to assess ischemia from a single CT scan. The accuracy figures are the company's own.