Medical Devices

KardioMobile Device Gets FDA Clearance for Bradycardia, Tachycardia Detection

Steve Duffy

April 25, 2019

The Food and Drug Administration (FDA) has cleared KardiaMobile (AliveCor), a personal ECG device, for use in detecting bradycardia and tachycardia.

Medicine

FDA to Update Medical Device Approvals Process

November 28, 2018

The FDA announcement came a day after the release of findings from an investigation into medical device safety worldwide.

Tech Talk

Would Device-Specific ICD-9 Codes Shed Light on Safety?

David Wild

August 15, 2017

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.

Next post in Tech Talk

Medical Devices

KardioMobile Device Gets FDA Clearance for Bradycardia, Tachycardia Detection

FDA to Update Medical Device Approvals Process

Would Device-Specific ICD-9 Codes Shed Light on Safety?

Medical Malware: How to Protect Yourself and Your Patients