Transoma receives FDA clearance for its ECG monitoring system

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has granted Transoma Medical 510(k) marketing clearance for its Sleuth electrocardiogram (ECG) monitoring system, an implantable, wireless heart monitor.

The St. Paul, Minn.-based Transoma said its Sleuth monitors heart activity 24/7 to provide diagnostic data for evaluating cardiac arrhythmias and other conditions, which often lead to infrequent, unexplained syncope.

Brian Brockway, Transoma’s chairman and CEO, said that this is its “first clinical product and is based on more than 20 years of experience with our remote wireless monitoring technology platform in biomedical research.”