Philips is recalling the software associated with its mobile cardiac outpatient telemetry devices after 109 patient injuries and two patient deaths, a Jan. 13 FDA recall notice said. The software was ...
With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says
On Monday, the FDA approved iRhythm Technologies, Inc.’s (NASDAQ:IRTC) 510(k) submission related to prior design changes to the Zio AT device via letter to file. Zio AT remains commercially available ...
iRhythm Technologies, a digital healthcare company specializing in cardiac telemetry products, received a warning letter from the FDA on May 25 detailing multiple issues with its Zio AT device. The ...
A suite of sensors, such as 1-lead ECG, SPO2, temperature, BP, and weight scale, that can be used by the patients at home and transmit their vital signs and other measurements to the cloud in ...
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