Marlborough medical device company CardioFocus has announced the Japanese Ministry of Health, Labor and Welfare has approved the company’s HeartLight X3 System for marketing in Japan.
“MHLW’s regulatory approval for the HeartLight X3 System marks another major milestone for our company as we continue to expand globally,” Burke Barrett, CEO and president of CardioFocus, said in the release.
The firm makes products to help treat irregular heartbeats and has recently expanded into both Europe and China.
CardioFocus is working with Japan Lifeline Co., Ltd., its exclusive distribution partner for Japan, to finalize reimbursement pricing, which is expected to be completed in August. Once reimbursement is finalized, the company will begin offering HeartLight X3 to patients and providers in Japan.
