Device manufacturer Medtronic has received clearance from Japan's Ministry of Health, Labor, and Welfare for its MRI-conditional Reveal Linq insertable cardiac monitor (ICM) system.
The agency also approved reimbursement for the device, which is designed for placement just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest. From there, physicians can diagnose irregular heartbeats.
Reveal Linq automatically and continuously detects and records abnormal heart rhythms for up to three years. It will be used in Japan in the diagnosis of unexplained fainting, known as syncope, and stroke of unknown cause, also referred to as cryptogenic stroke, Medtronic said.
