KardioMobile Device Gets FDA Clearance for Bradycardia, Tachycardia Detection
The Food and Drug Administration (FDA) has cleared KardiaMobile (AliveCor), a personal ECG device, for use in detecting bradycardia and tachycardia.
Medical Devices
FDA to Update Medical Device Approvals Process
The FDA announcement came a day after the release of findings from an investigation into medical device safety worldwide.
Would Device-Specific ICD-9 Codes Shed Light on Safety?
The current post-approval process also does not provide the FDA with a picture of how often a device is used, but having device-specific ICD codes would change that.
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