Dive Brief:
- Elucid received 510(k) clearance from the Food and Drug Administration for imaging analysis software designed to help physicians diagnose cardiovascular disease.
- The company’s PlaqueIQ software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.
- PlaqueIQ is based on pathologists’ analysis of microscopic tissue samples, leading Elucid to claim it is the first cleared software that objectively quantifies and classifies plaque morphology based on ground-truth histology. The company announced the clearance on Tuesday.
Dive Insight:
The FDA signed off on Elucid’s 510(k) clearance in September. Elucid said the software noninvasively quantifies and characterizes non-calcified plaque and its components such as lipid-rich necrotic core.
In a statement from the company, Mark Rabbat, a professor at Loyola University Chicago, discussed the importance of classifying and quantifying coronary plaque.
“Armed with additional data on vulnerable plaque components, we can make more informed treatment decisions on drug therapy selection or the need to send the patient to the cath lab,” Rabbat said. “I believe plaque quantification has the potential to greatly improve outcomes for patients while [realizing] tremendous savings to the healthcare system.”
Elucid is conducting beta testing on PlaqueIQ with a view to making the software available for limited release later this year. The company is also working to expand use of the software to noninvasive measurement of fractional flow reserve to measure coronary blockages and the extent of ischemia.
The clearance is an early milestone in Kelly Huang’s tenure as CEO of Elucid. Huang took up the position in July. Elucid, which raised $80 million to fund commercialization in November, highlighted Huang’s experience in areas such as market planning, physician engagement, sales and marketing in a statement to disclose the appointment.