Medtronic wins Japanese approval for Reveal DX cardiac monitor

Medtronic’s Reveal DX insertable cardiac monitor (ICM) has been designated by the Japanese government as a high-priority medical device, and is said to be the first insertable cardiac monitor to be introduced in Japan.

The Reveal DX ICM provides insight into unexplained fainting episodes, also known as syncope. Medtronic Japan will begin marketing the Reveal DX ICM once it has attained insurance reimbursement for the device.

The company will partner with Asahi Kasei for exclusive sales distribution rights for the device in Japan; Medtronic Japan will serve as the device’s designated marketing authorization holder.