Dive Brief:
- Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, the company said Monday.
- The updated algorithm shows a 21% improvement in plaque detection, compared to the original version of the technology, the company said.
- Heartflow disclosed the clearance alongside news that Cigna has become the second national insurer after UnitedHealthcare to update its policies to cover the plaque analysis product.
Dive Insight:
Using artificial intelligence, the product analyzes coronary CT angiograms, or CCTAs, to find and quantify plaque and thereby support the optimization of medical treatment strategies. A registry study linked treatment changes informed by the algorithm to reductions in LDL cholesterol.
Heartflow received Food and Drug Administration clearance for the first version of the product in 2022. The company began limited market education in the second half of 2023 but Heartflow FFRCT Analysis, its first product, still accounted for 98% of total revenue as of June 30. Heartflow has identified the ability to drive adoption of the plaque analysis product as a key factor that will affect its performance.
The clearance of the updated device gives Heartflow new features to emphasize as it seeks to grow sales of the plaque analysis product. Heartflow said the newly cleared technology has an updated algorithm and 3D color-coded visualization of plaque type, volume and distribution. The product is underpinned by data on 273,000 patients.
Cigna has agreed to cover the plaque analysis product starting in October. Radiology benefit manager EviCore included the product in updated cardiac imaging guidelines in July. The guidelines are set to come into effect at the start of October. Since the EviCore update, UnitedHealthcare and Cigna have said they will update their policies to align with the revised guidelines.
Heartflow has estimated the CCTA plus plaque analysis assessment is applicable to 5.5 million patients. The estimate informed the company’s calculation that there is a roughly $1.7 billion market opportunity. Heartflow raised more than $364 million last month in an initial public offering to fund its pursuit of the market.
