Aliso Viejo-based CathWorks, a medical device maker that provides 3D imaging of the coronary artery branch, announced in December the approval of its FFRangio system by Japan’s Ministry of Health, Labour and Welfare.
It’s the first such noninvasive device of its kind to receive approval in Japan, which is a difficult market for medical devices to win approval because of its stringent rules.
“Receiving Japan’s regulatory approval in such a short time is a significant milestone for our company that highlights the accuracy of our platform,” said Ramin Mousavi, vice president of global marketing and strategy at CathWorks, whose parent company is based in Israel.
This approval could help the company expand to other countries, Mousavi said.
CathWorks’ product takes a novel approach to helping doctors identify coronary issues. Currently, doctors often use a dye system to locate potential problems.
Its product is wire free and utilizes the 2D image of an angiogram to recreate a 3D color-coded image using proprietary AI technology.
The global market for products in this type of coronary catheterization is expected to reach $1.8 billion by 2025, according to Zion Market Research. The growth rate from 2019 to 2025 is calculated at 16%. Heart disease as whole global market was $67 billion at the end of 2018.
CathWorks announced a $30 million funding round last February.
(Editor’s Note: Alexa Corbett is the daughter of CathWorks CEO Jim Corbett.)
