05:43 PM EDT, 10/21/2024 (MT Newswires) -- IRhythm Technologies ( IRTC ) said late Monday the US Food and Drug Administration granted clearance for its 510(k) submission related to previous design changes made to the Zio AT device.
The device is a prescription-only outpatient cardiac telemetry device, commonly referred to as a mobile cardiac telemetry device, the company said. Zio AT is commercially available on the market to ship to customers in the US.
The company's shares were up about 17% in after-hours activity.
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