Home ECG Monitor Cleared by FDA

A monitoring device that allows heart patients to transmit a complete 12-lead electrocardiogram (ECG) from home or office over a standard telephone line with improved speed and convenience has been cleared by the U.S. Food and Drug Administration (FDA).

Called the CardioBeeper (CB12/12), the monitor features a prepositioned array of electrodes that transmit 12-lead ECG in about 12 seconds, nearly three times faster than previous technology. Primarily designed for monitoring patients who have cardiac symptoms such as chest pain or irregular heartbeats, the device is designed to transmit data to medical personnel who can provide diagnosis, advice, and treatment.

The CardioBeeper is manufactured by Meridian Medical Technologies, Inc. (Columbia, MD, USA) and is being marketed by Shahal Medical Services (Tel Aviv, Israel). The monitor was recently introduced in Israel by Shahal, which serves more than 60,000 subscribers in its home care monitoring program.

"The greater speed of the new CardioBeeper CB12/12 should result in even wider market acceptance because of improved patient convenience and more rapid response time at the receiving center,” said Jamil LaHam, general manager of Meridian's Cardiopulmonary Systems Group.



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