Evoke SCS System Approved for Chronic Intractable Pain
Evoke is a novel, closed-loop SCS system that instantaneously reads, records, and responds to evoked compound action potentials.
Medical Devices
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.
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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