April 25, 2022
Keio University Hospital
Xenoma Inc.
On March 1, 2022, insurance coverage began for the wearable Holter electrocardiograph (generic name: long-term ECG data recorder; brand name: e-skin ECG data recorder; medical device certification number: 304AFBZX00001000). The device was developed based on research for the Cabinet Office's Strategic Innovation Promotion Program (SIP), "AI (Artificial Intelligence) Hospital: Advanced Diagnostic and Therapeutic System," conducted jointly by Keio University Hospital (Hospital Director: Morio Matsumoto) and Xenoma Inc. (Headquarters: Ota-ku, Tokyo; CEO: Ichiro Amimori; hereinafter "Xenoma").
Long-term ECG testing is a common examination in the cardiovascular field, frequently used to detect arrhythmia and ischemia. In standard clinical practice, it is typically performed for 24 hours with 2 leads (two ECG waveforms). However, conventional Holter electrocardiograph measurements have faced various challenges. For instance, the need for healthcare professionals to attach and detach the device increases the number of hospital visits, and patients often avoid the test because their movements are restricted by cables and the recorder.
To solve these challenges, Keio University Hospital and Xenoma jointly developed a 3-lead (three ECG waveforms) ECG measurement system (hereinafter "the System") that patients can put on themselves without specialized knowledge. Following demonstration experiments at Keio University Hospital, the System was registered as a medical device by Xenoma and has now received insurance coverage.
The commercialization of the System makes it possible to conduct tests by mail, eliminating the need for hospital visits at the start and end of the measurement period, which were previously required. This is expected to contribute to improving equity in medical access across different regions. Tests using the System will be offered by Xenoma to medical institutions starting in May 2022.
For the full press release, please see below.